Read the full story on Healthcare Mitttelhessen.
Missing values among collected data are not uncommon and there are several different reasons for their occurrence, some of which are inevitable.
Performing a thought-out imputation can help to obtain reliable statistical results even for high rates of missing values. In this article we are trying to give a basic understanding on the topic by having a look at what imputation means at all, what types of missing data exist, what pros and cons for different methods (exemplary) exist, and what multiple imputation is.
In a bottom line, we are summarizing some advantages of imputation and point out when you could make use of that newly acquired information. So let’s get started …
To perform an imputation means to fill in missing values with random draws from an imputation model and then fit the imputed data to an analysis model.
Therefore, the point of imputation is not that the imputed values look like observed values. It is rather that the imputed variables should act like the observed variables when used in analyses.
Nevertheless, any kind of imputation introduces some sort of bias as we cannot know what the ‘real’ data actually looks like. The best we can do is trying to get as close to the ‘real’ data as possible by minimizing any bias and for that we need to choose the right methods.
Not only to choose an appropriate method but also to validate if imputation does make sense at all, the first thing to ask is ‘What kind of missing data are we looking at?’ and yes, missing data does not equal missing data!
At this point our statisticians would like to come up with lots of formulas and mathematical language, but for now we try to keep it simple. Generally speaking, there are three different types of missing data.
Missing completely at random (MCAR): A variable is missing completely at random when the probability of its ‘missingness’ does neither depend on other (observed) variables nor on itself. An example for this would be missing data for respondents, whose questionnaire simply got lost in the mail.
Missing at random (MAR): A variable is missing at random when the probability of missing data on that variable is not related to the variable itself but to other measured variables. If, for example, men are less likely to answer a survey about depression, then missing data about the grade of depression will be related to the variable ‘gender’. Within each gender, the probability of missing ‘grade of depression’ does not depend on the grade of depression itself.
Missing not at random (MNAR): A variable is missing not at random when the probability of its ‘missingness’ is related to the variable itself. A typical example for this would be the variable ‘income’. The higher the income of a subject, the less likely the related question gets answered.
Once we know what we are dealing with in the first place, we can start to think about proper imputation methods.
When trying to find the best imputation method to be applied to your data, both advantages and disadvantages of each potential method have to be considered.
As a basic example, we take a look at ‘imputation by mean’. This might work well on small datasets with numerical variables as it keeps the mean unbiased but gives poor results on encoded categorical variables. ‘Imputation by most frequent values’ on the other hand works great for categorical variables but may introduce even greater bias.
Needless to say that those two methods are rather simple, as both do not even factor in the correlations between variables, and are therefore not recommended to be used anymore.
Modern methods of imputation are (almost always) way better as they take more factors into account which, however, render them more complex. ‘Imputation using k-NN (Nearest Neighbor)’ for example can be much more accurate than the methods mentioned above. In this procedure the k nearest neighbors of a missing observation are taken into account, based on other observed values, for imputation. The challenge here is to define k. A low k will increase the influence of noise and the results are going to be less generalizable. A high k on the other hand will tend to blur local effects which are exactly what we are looking for.
Further methods of imputation would be regression imputation, in general the overlaying process of multiple imputation or methods based on deep learning and/or machine learning, just to name a few approaches.
The more complex a method, the less comprehensible the pros and cons, at least without a closer introduction, leading to another important indicator when searching for the best method: Complexity itself!
The complexity of imputation methods can be both an advantage and a disadvantage. Even though approaches like MICE (Multivariate Imputation by Chained Equations) perform extremely well when properly specified, these might be exaggerated depending on what data we want to impute and what analysis we want to perform. In that case, we can save time and resources by choosing a less complex method with a negligible loss in performance.
Although we have just scratched the surface here, it already became clear that imputation is no easy fix for the missing-data problem.
In the entire process of imputation statistical/mathematical knowledge and experience in the data to be imputed have to be brought together. This requires a close cooperation between statisticians and field experts. The reward can be to gain as much and as reliable knowledge from incomplete data as possible.
Especially for huge databases and registers and data which has been collected or merged without having a specific goal in mind in the first place, imputation can serve as a highly beneficial, hypothesis-generating approach.
If this topic caught your attention or if you are interested in coorperating with us, please don’t hesitate to contact us.
At Alcedis, we try to care best for your questions and inquiries! Thus, we decided to reorganize our support and helpdesk team.
Via telephone number +49 (0)641 / 944 36 36 and email address email@example.com, you will reach our Alcedis Support Hotline. Please choose this number/email address for all study specific questions, e.g.
Via telephone number +49 (0)641 / 944 36 0 and email address firstname.lastname@example.org, you will reach our Alcedis Front Office. Please choose this number/email address for any other general inquiries to Alcedis, e.g.
If you are uncertain which way of contacting is best for your question or inquiry, just choose one option! Of course we will forward you to the correct contact person…
We are looking forward to assist you!
In this year’s Christmas game you have supported the ‘Happy Alcedo’, our little logo bird, on his adventurous flight route collecting small gift packages and thus achieved a new record sum! 4.009 € – as much as never before – were won for non-profit organizations such as:
We would like to thank all of you for your active and growing participation in our fun little Christmas tradition, of course also on behalf of all happy donees, and wish you a good and successful start into the New Year.
Capture of real-world data of treating melanoma patients across Europe
The collection and evaluation of real-world data is of particular importance for the further development of treatment strategies, clinical guidelines and future innovation for prevention, diagnosis and treatment of cancer.
In approval studies the application of study medication is recorded and tracked in detail. However, documentation that goes beyond the data captured within clinical trials, as follow up treatment and outcome, is scarce. Hence, data that are of high value for patients, physicians and pharmaceutical companies alike are often lost. First attempts to close the knowledge gap are provided by cancer registries collecting real-world data.
In this context, data from patients that are usually excluded from clinical trials are collected. However, in contrast to clinical studies, these are often in operation in single countries only.
To provide both an alternative to ad hoc high-resolution studies and obtain knowledge on an international level EuMelaReg has been launched is year! The EuMelaReg registry collects existing data on melanoma patients throughout Europe and integrates them in a Data Warehouse operated by the EuMelaReg consortium.
Since its foundation this year, the EuMelaReg consortium has constantly been gathering speed and seven European countries have committed themselves to the scientific goals of the consortium already.
Alcedis is proud to be part of this scientific adventure and provide it with the IT infrastructure and long-standing Big Data expertise required for meeting the challenges of this international registry. From the data quality perspective the major challenges are the following:
• How can heterogeneous data structures and formats be easily merged?
• What methods can be applied for missing data fields and adjustment of inconsistencies?
Bearing in mind that restrictions on privacy and processing of bulk data making the use of well-established means for data cleaning either not feasible or too expensive.
Two highly promising ways to achieve a sound data quality are the implementation of specific validation schemes on a national basis and the application of advanced statistical methods.
You want learn more about this pioneering project? Contact us at email@example.com.
For years electronic exchange of ICSRs with the EudraVigilance database in an e2b-compliant standard has become mandatory for all MAHs of medicinal products. However, ICSRs from the CRO’s clinical database to the MAHs in both, non-interventional studies and clinical trials, are still transmitted paper-based or in electronic portable document format (pdf).
The benefits of using the e2b standard in exchange of ICSRs between the CRO and the MAH are hardly recognized, in particular the automated and highly efficient fail-safe transfer of validated datasets ready for immediate processing. Alcedis’ long-term experience in implementing customized requirements in pharmacovigilance as part of the AlcedisTRIAL software is the key for next level data exchange beween clincial and safety databases: Alcedis is ready for e2b (R3)!
Are you too? Our IT and pharmacovigilance experts are glad to customize the perfect e2b (R3) solution for you!
As our favourite Christmas tradition at Alcedis this year´s fundraising game was quite a challenge of skill and patience. A tiny ball had to be skillfully navigated through a tricky maze where the Alcedo bird marked the successful game at the finishing line.
We thank all participants and gladly forward the donations and your kind Christmas greetings to the non-profit organizations DKMS, Deutsche Kinderkrebsstiftung, Greenpeace, Mèdecins Sans Frontières, NABU and WWF.
The New Year feels like a tricky maze to you already? Give us a call and let Alcedis assist to mark YOUR success in 2018!
Das Trendwort Digitalisierung ist allgegenwärtig und prägt auch das klinische Studiengeschäft. Der klassische Papierfragebogen ist fast vollends dem web-basierten eCRF gewichen, doch ist das längst nicht alles. Die elektronische Erfassung und die Lieferanten von Studiendaten sind mannigfaltig.
Betrachten wir zunächst die sogenannten Wearables. Wir kennen viele davon aus dem alltäglichen Gebrauch. Nehmen wir das Beispiel der Fitnessarmbänder. Sie liefern wertvolle, zusätzlich Daten zur körperlichen Aktivität des Patienten. Via Smartphone App können diese Daten gesichert in die Studiendatenbank übertragen und mit klinischen Daten korreliert werden. Im Rahmen einer Pilotstudie in Canada konnten wir bereits erfolgreich ein solches Studiendesign umsetzen und bei Patienten mit einer Herz-Kreislauf-Erkrankung hierdurch Aktivitätssteigerungen während des Studienverlaufs zeigen. Einen spannenden Ausblick bieten hier ohne Frage auch geplante Langzeitstudien zum Thema Krebs und Bewegung. Die Möglichkeiten der Datensammlung über Wearables oder auch Medizinprodukte sind gigantisch: ob biosensorische Daten wie zum Beispiel Temperatur, Herzschlag, Blutsauerstoff oder Glukoselevel bis hin zum Übertragen der Blutkonzentration pharmazeutischer Wirkstoffe. Auch Daten zum Nutzungsverhalten, z.B. über den Insulininjektor oder den Asthma-Inhalator liefern wertvolle Daten zur Adhärenz.
Patientenzentrierte Fragestellungen, zum Beispiel zur Beurteilung der Lebensqualität aber auch zur Erfassung der Patientenpräferenz sind kaum noch aus Studien wegzudenken. Das Smartphone als unser ständiger Begleiter, oder auch Tablet-PCs spielen hierbei mittlerweile eine wichtige Rolle. Insbesondere für die sogenannten Patient Reported Outcomes (PRO), also den altbewährten Patientenfragebogen, in der elektronischen Variante kurz ePRO genannt, sind papier-freie Lösungen hervorragend geeignet. Die Akzeptanz durch den Patienten ist meist hoch . Zudem sind ePROs im Hinblick auf die Datenqualität und –Vollständigkeit der Papiervariante überlegen . Vor allem die Vollständigkeit der Daten kann zusätzlich noch durch Erinnerungsmitteilungen gesteigert werden, die zu den Standardfunktionen der Smartphone Apps gehören.
Erinnerungsfunktionen spielen aber grundsätzlich eine wichtige Rolle, besonders seit der Einführung oraler Tumortherapeutika, da die Therapie nun nicht mehr ausschließlich in der Arztpraxis verabreicht wird, sondern die eigenverantwortliche Einnahme durch den Patienten erfolgt. Die Erfassung und Verbesserung der Medikationsadhärenz hat somit eine massive Bedeutung für den Therapieerfolg. Auch in der gynäkologischen Onkologie kommen oral verabreichte Medikamente wie z.B. endokrine Therapien, PARP-, mTOR-, oder CDK4/6-Inhibitoren und andere orale Tumortherapeutika zunehmend zum Einsatz.
Hier bringen wir in einigen Studien Alcedis eMARS (electronic Medication Adherence Reminder System) zum Einsatz. Eine App, die Patienten über SMS oder Push Benachrichtigung erinnert, wenn die Dokumentation von Medikationseinnahmen vergessen wurde. Alcedis eMARS kann zusammen mit einem elektronischen Patiententagebuch genutzt oder in den Studien eCRF integriert werden. Alcedis eMARS berücksichtigt dabei die individuellen Therapie Schemata (z.B. gemäß Studienprotokoll) und vergleicht die Eingaben des Patient und des behandelnden Prüfarztes. Dieser wird im Übrigen durch die zusätzlichen Möglichkeiten der Arzt-Patienten Kommunikation über mögliche Toxizitäten informiert.
2. Ganser AL et al. Data quality and power in clinical trials: a comparison of ePRO and paper in a randomized trial. In: Byrom B und Tiplady B. ePRO:electronic solutions for patient-reported data. Gower Publishing, Ltd., 2010;49-78
As a part of the G20 process to strengthen economic growth, the B20 Health Initiative has been launched to ensure an exchange platform for the actors in global health to drive innovative health systems. The B20 Health Conference will be held the 18th of May under the headline: Resilient Health Systems Shaping the Future of Health Care Together.
An important theme at the conference is Innovation in Healthcare in order to advance technologies and methods to cope better with diseases and improve health on a global scale.
In a dialogue about the role of digital health, Mr. Lorsbach will participate as discussant on perspectives for transforming tomorrow’s Health Systems. He will contribute with his extensive knowledge and more than 25 years of experience from health care research, as the co-founder and CEO of Alcedis. Through innovative solutions and collaborative thinking Alcedis is taking small steps every day towards a vision of improving and digitalizing healthcare research.
On the 27th of April is the Girls and Boys day at Alcedis.
During the day of the event the students have the opportunity to take a closer look at professional fields, which are otherwise rarely considered. Alcedis Girls Day also offers two girls the chance to expand their spectrum of career options and gain insights into the profession of an IT specialist.
Alcedis has taken one more step in the process of safe and fraud proof data capturing in clinical trials.
The Alcedis eCONSENT plugin allows patients to sign up fully digital for a trial. The Alcedis eCONSENT is designed to capture
these on external devices such as tablets and thereby substitute the paper based signature. In addition, a remote monitoring
process is performed to check and verify the presence of the patient signature and ensure that no data is captured before the
signature hs been given.
We have optimized the process of releasing updates and running maintenance work in our software applications, such as our eCRFs for clinical studies. Zero downtime in action means from now on 100 % availability of our systems at any time!
This year’s fundraising game was inspired by the popular Angry Birds game and like last year the participants could freely choose between different non-profit organizations to whom they wanted to donate the money. With a total sum of 3.504 € we thank all participants and we are proud to donate the money to the following recipients:
Deutsche Kinderkrebsstiftung, WWF, Ärtze ohne Grenzen, Kinderhospiz Bärenherz, Hospiz-Verein Gießen e.V., Kinderhospiz Löwenherz, Greenpeace, NABU, Aktion Deutschland Hilft e.V. and UNICEF.
From the 3rd quarter of 2016 our popular tumor documentation software AlcedisMED is offered to you as an open source project. To promote this essential tool for valuable health care research, the switch from a plain commercial use towards a free-of-charge solution for everyone is the first step.
AlcedisMed is software for the documentation and evaluation of all tumor diseases certified by the German Cancer Society/OnkoZert. With over 10 years of experience in this field of expertise, we realized that this kind of data collection should be available for a wider range of users – namely free of charge and for everyone!
All information and downloads regarding our steady tumor documentation software without any obligations can be found on www.tumordokumentation.alcedis.de, where we also provide a tutorial of how to install and use the program for the first time.
Do not hesitate to register here to receive notifications when there are exciting news about the open source project AlcedisMED.
When treating serious diseases two principles are for sure. First: Not taking your medicine is usually not an option. Second: Yet, a huge population of patients will show a decrease in adherence rates heading forward with their therapy – this has been demonstrated in many studies! The questions of why this phenomenon occurs in almost all therapeutic areas and what can be done as preventive actions can be answered in many ways. For the latter let’s start with one of the most obvious: Reminding patients!
In this context, patients’ smartphones have proved as a very useful platform in clinical trials. Therefore, Alcedis has developed eMARS (Alcedis electronic Medication Adherence Reminder System) to inform patients via push notification or SMS when they have forgotten to take their medications. Alcedis eMARS can be connected to a patient’s diary App, the clinician’s eCRF or any other electronic patient record. Before sending a reminder message, eMARS will compare individual therapy schemes (for example as defined in the study protocol) with documentations done by the patient and/or the clinician.
Looking into the future there will be more advanced methods like sensors that can detect specific coatings of pills and therefore will deliver an almost fully automated mechanism to check for the intake of medications (check http://www.proteus.com), or completing medical devices (e.g. an asthma inhalator) with additional counting devices (check https://www.propellerhealth.com) to monitor their usage. These methods are still very limited in their general availability but they are on our radar for integration into future studies.
Learn more about Alcedis eTools in the upcoming Episode 3
Wearables can detect and track a broad range of bio sensory data. It starts with basic, externally captured information like body temperature, heart rate or simply counting the steps you make. More advanced systems are able to measure your blood oxygen, blood glucose or even the blood level of active pharmaceutical components. Captured data can simply be transferred to smartphones and as such directly into a clinical trial database – in real time! This is an important feature to allow healthcare professionals to directly monitor patient data.
Alcedis has taken over a leading role amongst German CROs combining classical CRO Services and IT Solutions. Consequently we have successfully performed various studies integrating wearables. Most recently we just completed the recruitment for a study in Northern America that has equipped patients with FITBIT® Tracker to determine the change of their physical performance in the
course of their treatment.
Wearables are just one technical highlight amongst many other eTOOLS that can be integrated into a clinical study.
And now – what’s your next move?
From January 12, 2016 Microsoft will discontinue Support for older versions of Internet Explorer (IE). Thereafter, the IE version 11 only gets security updates and technical improvements on the operating systems Windows 7, Windows 8.1 and Windows 10. Users of these operating systems should upgrade to the latest version of the browser.
Due to performance and security issues we will stop supporting Microsoft Internet Explorer prior version 11 in our applications after the 1st of March 2016.
If you are using Internet Explorer prior version 11 please upgrade to a higher version or use the latest versions of Mozilla Firefox or Google Chrome.
In general we recommend keeping your web browser up to date to ensure optimal protection and performance!
As a member of the GAMP R&D and Clinical Systems special interest group (SIG), Alcedis will participate and contribute to the GAMP GCP conference in Mannheim, Germany. Read more about the 7th official GAMP 5 conference.
Thanks to the ever-growing number of projects in Northern America, the Alcedis Inc. was founded this year in the US and recently an office in Manhattan was opened. The team in New York, consisting of project manager, study administrator and clinical research associates will be in charge of the Alcedis projects in the US and in Canada. They will be strongly supported by their German colleagues from the core business units which are still located centrally in Gießen such as Data Management, Pharmacovigilance, IT Solutions and Biometrics. The activities in Northern America are not only focusing on those major pharmaceutical manufacturers which are already closely connected to Alcedis due to many years of ongoing cooperation’s, but also smaller US biotechnology companies that are aiming for new markets in Europe and particularly in Germany.
As a member of the DIHK – Committee on Health Economics, the Alcedis GmbH participated with a lecture on Big Data in clinical research. The main objective is the development of a DIHK position paper. The kick-off meeting of the working group took place in form of a workshop in Berlin. Companies from various sectors presented their business model and the application / use of Big Data technologies in their industry.
Until May 21, 2015 we will convert our authentication procedure for our software AlcedisTRIAL. All of our clinical studies will be affected by this change. After this conversion all users will be automatically requested to provide responses to 2 security queries during the first login. Furthermore a telephone or fax number can be optionally entered in order to request a security PIN. In the future, this conversion will improve and accelerate the procedure if you have forgotten your password.
For further questions please contact our support team by phone: +49 641 94436-36 or via email: firstname.lastname@example.org.
At the Girl’s Future Day on April 23, 2015 we invited two girls to gain insights into the profession of software developer. For questions and information, please do not hesitate to contact us at 0641 – 944 36 0!
On April 16, 2015 the Giessen Graduate Center for Life Sciences organized their 6th Career Day. Under the motto “Pathways into Industry”, the participants were able to get to know regional companies in the life science industry and were able to gain an impression of the many career paths in biotechnology, clinical research, pharmacy and chemistry.
Alcedis GmbH also presented its versatile range of applications in the field of medical research. With the lecture “From Stable to Desk”, Michael Städele (Department Manager Data Management) explained the career profile of a Clinical Data Manager and the associated professional and personal competencies of the potential candidates. At the end of the lecture, interested parties were given the opportunity to talk about their opportunities for entry at Alcedis GmbH in a personal meeting with Mr. Städele.
Prior to the “Girl’s Day” on April 23, city councilor Astrid Eibelshäuser and the head of Department for Economic Promotion of the City of Giessen, Sabine Wilken-Görich, visited the “Alcedis Clinical Research – it Solutions” in Europaviertel, Giessen. Alcedis has been involved in “Girl’s Day” for many years. This special day is about inspiring girls for “MINT” – ie, the areas of mathematics, computer science, science and technology.
Companies should be aware of the current and future need for skilled workers and if possible help provide the necessary skills. To improve basic training: Alcedis GmbH is mainly looking for specialists in the field of informatics. The managing directors, Dr. Elke Heidrich-Lorsbach and Michael Lorsbach, emphasized the need to improve basic school education. Girls, according to Heidrich-Lorsbach, are “unfortunately underrepresented” in the field of computer science. This is why “Girl’s Day” is a great idea.
“There will be a lot going on in the field of computer science in the near future, so we need to stay up to date in Germany in order to be able to compete internationally,” said Michael Lorsbach. This includes the company’s new plans in the immediate area of its current office building. Eibelshäuser and Wilken-Görich expressed their support and were glad that the company wanted to expand its Europaviertel site.
Alcedis now employs more than 100 people, of which more than 100 are at the Giessen site and another nine in the Hamburg office. An additional office will be opened soon on the east coast of the USA. Alcedis was founded in 1992 by Michael Lorsbach and Elke Heidrich-Lorsbach in Giessen. As an independent contract research organization (CRO), it offers a full service CRO portfolio for clinical research, clinical trials, medical device studies and health care research.
On 23rd of April is Girls’ and Boys’ Day again. Young students, especially girls, will have the opportunity to get an insight into various professions that are typically dominated by men.
As in former years Alcedis offers girls the chance to explore and expand their range of career choices.
Astrid Eibelshäuser, Head of the Department for Education in the city of Gießen, will visit Alcedis and learn about the companies contribution to the Girls`Day but will also talk about career chances at Alcedis in general.
On March 18th we were glad to welcome again many users of our AlcedisMED tumor documentation, now for the second time in our head office in Gießen!
Interested physicians and medical records technicians from all over Germany joined the meeting for the exchange with other users and to catch up on new developments in tumor documentation and evaluation.
One of the main topics was the introduction of OnkoZert´s “OncoBox Darm” which can be used in combination with AlcedisMED for some time now. A first glimpse on the “OncoBox Prostata” and the discussion about several alterations for breast- and gynecological cancer centers completed an interesting and informative day.
Last but not least we want to say “Thank you” to all participants for coming and of course the valuable feedback and the many suggestions we received from you!
The Alcedis GmbH was honored by the Chamber of Commerce Giessen-Friedberg as ‘Training Company 2014’ in recognition of special achievements in vocational training.
Under the headline “Introduction to Systematic Software Testing” approximately 20 students together with Professor Wüst, visited Alcedis in Europaviertel in Giessen.
One of the founders and CEOs Dr. Elke Heidrich-Lorsbach gave an introductory lecture about the company’s orientation as well as its entrepreneurial strengths by the software solutions developed in the field of clinical research. A follow-up speech by department head Dr. Marina Mangold dealt with the internal interface between the medical departments and IT. The conclusion was the presentation by Mr. Dirk Aevermann, an experienced software developer, who presented details of the software testing procedures in the company. Here the students were able to hear how the methods in the lecture were actually used in practice.
Alcedis offers graduates an attractive work place but also regularly provides places for internships or temporary jobs in the IT environment.
The handball minis of the TV Hüttenberg are receiving new jerseys. The Alcedis GmbH donated ten jerseys to the mini athletes and keep fingers crossed for the upcoming games. Click here for the newspaper article in the Gießsener Zeitung.
Again the fundraiser game was played diligently this year and plenty of donations were generated. With the idea of “you play and win – we donate” our website visitors had fun playing games whilst generating funds and finally decide to which profit organization Alcedis GmbH will donate those profits. Several hundred participants have played together and generated 1,547 Euros which were rounded up by Alcedis GmbH onto 3.000 Euros. The recipients were: Aktion Deutschland Hilft e.V., Ärzte ohne Grenzen, Deutsche Kinderkrebsstiftung, Greenpeace, Hospiz-Verein Gießen e.V, Kinderhospiz Bärenherz, Kinderhospiz Löwenherz, NABU, UNICEF, WWF. We say „Thank you!“ to all participants and wish all of us a successful year!
With the 1st of January 2015 Alcedis is becoming official sponsor of the German basketball league team GIESSEN 46ers.
The mustaches are gone and the shaven faces of our male colleagues are back in shape. But more important: the donation bag of the Movember foundation is 200 € heavier. We say thank you Mo Bros, Mo Sistas and all supporters.
As a member of the GAMP R&D and Clinical Systems special interest group (SIG), Alcedis will participate and contribute to the 7th official GAMP 5 conference in Mannheim, Germany. Read more about the 7th official GAMP 5 conference.
Meet Alcedis at the 2014 EU GCP Inspectors Working Group Workshop of the European Medicine Agency (EMA) in Paris.
Click here to find out more about the working group.
Study data in CDISC?
The Study Data Tabulation Model (SDTM) of the Clinical Data Interchange Standards Consortium (CDISC) represents the future standard for the export of clinical data.
Also recognized by the FDA, a standard like this allows to subject data from different studies in a simple way to a meta-analysis. CDISC data export is already a requirement of many of our customers. However, only few know what kind of effort is necessary to prepare and process the data. Thus, the sponsors requirements (annotated CRF, metadata and code lists) must be checked for SDTM compliance, furthermore based on the CRF a mapping must be created and implemented. And of course, these processes are subject to an internal validation again.
Supported by cccp (www.3cp.biz) Alcedis has already built up an extensive expertise and conducts CDISC-compliant data exports on demand.
Today our tumordocumentation system AlcedisMED has been officially approved for OnkoZert´s OncoBox Darm!
We would also like to thank our pilot centre for the efforts and the kind cooperation!
To find further information visit www.oncobox.de or use our secured area of AlcedisMED.
As in former years the Mathematikum proceeds with the project “MINT: Experience the future – the stars of tomorrow” into the next round. The goal is to present various professions from the MINT disciplines (mathematics, computer science, natural sciences and technology) to the participating students. As an apprenticing company in computer science the Alcedis has a great interest in promoting the “Stars of Tomorrow” and is therefore, as on previous events, presenting the job of an IT specialist.
The validation of electronic system for data capture is a central issue in clinical research for quite some time and is increasingly drawn into focus of audits and inspections. This raises a need for guidelines regulating GCP relevant systems. Alcedis is an active member of the ISPE SIG group for several years. Now the second concept paper on “Validation and Data Integrity in e-Clinical Platform” was published.
As a member of the Committee itself Alcedis is dedicated to the needs and interests of clinical research in Germany. At this event the Alcedis management gave a speech on current developments in the field of clinical research followed by a discussion with the Federal Minister for Health, Hermann Gröhe, about opportunities and challenges of the health care industry.
Alcedis sponsors new shirts for the football juniors of the MTV who enjoyed wearing the colours of the german national football team. We wish you good luck but first of all: Have fun!
Starting the new school year on august 1st 2014 our IT department welcomes two new apprentices to be trained as application developer. We say welcome and wish you a good start at Alcedis!
Alcedis has been invited to give a lecture on “Risk Based Monitoring in Clinical Trials” at the ePharmaDay in Frankfurt am Main, Germany. Read more about the ePharma Day.
ATTENTION: After April 8, 2014, official technical support for Windows XP will no longer be available. This includes automatic security updates on Windows XP or the Internet Explorer 8 that help to protect your PC.
Due to performance and security issues we will stop supporting Internet Explorer under version 9 in our applications after the 1st of June 2014.
If you are using Internet Explorer prior version 9 please upgrade to a higher version or use the latest versions of Mozilla Firefox or Google Chrome.
In general we recommend keeping your web browser up to date to ensure optimal protection and performance!
On Girls´Day (March 27th 2014) Alcedis invites two girls to have a closer look at the job of a software developer.
Join one of our software developers by creating your own website! Learn which tasks a software developer has and try creating your own little programm. At the end of the day you will have built your own website to show your friends and family!
If you have any questions don´t hesitate to contact us at +49 641-944 36 0!
Want to learn more? Subscibe here!
We want to invite all users of the AlcedisMED tumordocumentation to our user meeting at the German Cancer congress 2014 in Berlin.
Meet us at Feb 20th, 01:00 pm to 05:00 pm
Please find the registration documents in the internal area of AlcedisMED.
We are looking forward to hearing from you!
Our tumordocumentation software AlcedisMED is currently in a verification process for OncoBox.
Good news for all users of our documentation module “Prostate Cancer Center”: AlcedisMED is now participating in the pilot phase of OncoBox Prostate
Alcedis has been invited to give a lecture on “EDC Systems in clinical trials”. Read more about the European Academy of Senology.
Alcedis has been invited to join the congress and give a lecture on ‘Tumor Registry Programs’.
As member of the ISPE SIG Group, Alcedis has been invited to participate at the annual meeting of the International Society for Pharmaceutical Engineering (ISPE) in Washington DC. In the session on Clinical Data and Systems, Ms. Dr. Marina Mangold (Head of eClinical Solutions, Alcedis) and Mr. Frank Henrichmann (Associate Director TQM, Parexel) will give a lecture on ‘Agile Project Management for implementation of regulated (GCP and GMP) systems’ (Sunday, 3rd of November 2013; 15.45 – 16.30, Session 106). Learn more about the 2013 ISPE Annual Meeting.
Clinical research has been facing some major changes in the last years with the continuous exchange of paper based processes for modern electronic data capture. As a consequence of this step the validation of electronic system has been drawn into focus of audits and inspections. This raises a need for guidelines regulating GCP relevant systems. Alcedis is an active member of the ISPE SIG group for several years. This work resulted in a recently published concept paper which harmonizes GAMP 5 principles and GCP requirement for electronic data capture (EDC) systems in a practical approach. Read the full paper here: The Application of GAMP 5 to the Implementation and Operation of a GxP Compliant Clinical System.
Embedded into the event Alcedis CEO Mr. Michael Lorsbach will give a lecture on how software development must be set up to meet the rapidly changing requirements of users and institutions such as DKG, Onkozert cancer registries etc. In addition there will be a forum for AlcedisMED users to discuss their experiences and questions on tumor documentation and data analysis.
A mixed team of Alcedis employees is going to participate at Gießens first company running event.
The past few years have seen many changes for our company: Continuously growing staff, stronger presence on foreign markets, our thriving global partner network, groundbreaking software innovations and last but not least our new company building in Gießen’s Europaviertel [European Quarter] and the establishment of a new branch office in Hamburg. To reflect these changes, the brand Alcedis has now also undergone optical changes: a new company logo plus a fresh look for our internet presence.
The common kingfisher’s scientific name Alcedo atthis was the inspiration for our company name when the company was founded. Alcedis’s headquarters in Gießen are surrounded by wide expanses of green and water. The kingfisher is a frequent sight there and can now also be found in our new company logo.
We will, however, stick with the colours yellow and red that still – just like in the old logo – represent Alcedis’s core competencies: The close interaction between CRO Services & Software Development!
An article by Dr. Elke Heidrich-Lorsbach and Hanno Härtlein published in “Onkologischen Pharmazie“, issue 2/13 for the 5th oncological pharmaceutical convention NZW-Dresden on the 14th of June 2013.
As a member of the panel of health management from the chamber of commerce Alcedis is participating regularly on their meetings. The last was held on the 16th of May 2013. On the previous day we had the opportunity to attend the talk of „politics and health management of the future“ and exchanged some views with the german health minister Daniel Bahr (FDP).
At the grand opening event of the initiative (founded by the BVMW Hessen) on 16 April 2013 in Bad Nauheim, the Alcedis GmbH was awarded in the category “nutrition” by initiative patron Joey Kelly.
Together with our clients, employees and representatives of politics and society we celebrated the grand opening of our new company headquarter along with an exciting, scientific programm.
Our speakers included e.g. giessen´s mayor Dietlind Grabe-Bolz with a welcoming speech, Klaus von Dohnanyi (former mayor of Hamburg and former minister of science and education under the Willy Brandt administration), Professor Wolfgang Wick (medical director of the national tumorcentre from the university hospital of Heidelberg), Professor Peter Kneisel from the university of applied sciences in Gießen and Professor Peyman Hadji (leader of gynaecological endocrinology, reproductive medicine and osteology of the university hospital of Gießen and Marburg).
Learn more in the article .
Finally it´s happening. On the 1st of may all of our approximate 10 employees can move into the new office rooms. Located in the heart of Altona (Königsstr. 28) our staff can take up their work.