WHERE INNOVATION MAKES A CHANGE

 

Clinical Development

As an independent Contract Research Organization (CRO), Alcedis GmbH offers with a full service portfolio all activities required for clinical research and successfully conducts phase (I), II-IV clinical studies as well as non-interventional studies in line with international standards. Alcedis connects solid experience in various indications with global presence. Studies on medical devices also belong to our range of services. Further essential issues are translational research as well as health care research. The long cooperation with leading hospitals and registered specialists allows us to reliably select experienced study sites. Our ever growing partner networkAlcedisCONNECT ensures a consistently high quality standard. With our study software AlcedisTRIAL we offer a valid solution according to international standards for the entire scope of study duties. The composition of CRO services and in-house software development is an outstanding characteristic of Alcedis which allows an effective and reliable implementation.

Scientific Consulting

With our Scientific Consulting services we develop together with our customers scientific concepts and product strategies to introduce or establish innovative substances and medical devices in the therapeutic environment. This includes scientific advice, research and analysis in the respective therapeutic area. We combine many years of experience in daily therapeutical routine with sound scientific expertise and our commitment to create sustainable value for all stakeholders.

Depending on the requirements we provide a team of internal and external experts. The Alcedis Biometrics provides sample size scenarios and the statistical design to ensure a reliable achievement of the planned endpoints. Together with the indication experts of the Medical Writing a steady scaffold for the scientific and financial planning is set-up.

Clinical Operations

The Clinical Operations Department accompanies the clinical trial from the compilation of the trial protocol over Monitoring to the final clinical report and manages and supervises the conduct of the projects in compliance with GCP rules.

Medical Writing

The Medical Writing accompanies the project starting with the creation of first study outlines u to the final clinical study report. The team is specialized in various indications and works closely with external medical experts whenever needed.

Further all other documents in the course of study such as patient information, study protocol or observational plan, amendments, newsletter, publications or value dossiers are on the task list of the team.

Learn more about Alcedis Medical Writing

Data Management

Our Data Management accompanies the clinical trial from the compilation of the Data Management and Data Validation Plan over Query Management to the closure of the database and giving over data for biometrical analyses. Our software solution Alcedis TRIAL pictures any data management activity. This permits effective communication with the sites as well as secure logging of all data revisions.

Pharmacovigilance

Our Pharmacovigilance Department attends all safety aspects of a clinical trial. In combination with the plugins of our Study Software AlcedisTRIAL, among other occurrences the receipt and forwarding of (S)AEs and SUSARs are monitored and regular reporting and reconciliation of the sponsor’s study database and safety database conducted.

Biometrics

Biometrics supports the sponsor with the entire service range for a clinical study – from planning to the final report.

The statistical methods and validity of the collected data are crucial for significant results. Alcedis Biometrics is therefore already involved in the planning of the study at an early phase and cooperates closely with the Data Management Department and Clinical Operations Department.

From the very beginning of each project statistical parameters play an important role to ensure the overall success of a clinical trial. Thus, the calculation of significant sample sizes is fundamental to the strategic design and should therefore be chosen carefully.

We would be glad to help you with your sample size calculation! Learn more about basic considerations on how to make your project successful.

GCP Trainings

The basic course for medical and non-medical members of the study group, study coordinators, sponsors, and pharmaceutical industry personnel!

The training is particularly aimed at beginners in the field of clinical research, but also suitable as a refresher course for advanced level personnel to update or deepen their knowledge.
All seminars will give you a comprehensive insight into good clinical practice (GCP) and the latest regulatory changes. Discuss your experiences with our professional lecturer.
The 1- or 2-day seminar is certified by the Medical Association of Hessia / Germany (“Landesärztekammer Hessen”).

 

Current training courses can be found in the section Events: https://www.alcedis.de/en/category/events/