Expertise

DMC Management

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Clinical studies

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Professional expertise

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At DATAN we only provide services when we are absolutely confident that our contribution will be delivered to the highest quality standards and to the required timescales.

With over 500 completed clinical projects in many different therapeutic areas and clinical phases, we are experts in this field and can provide you with the best advice and services to meet your biometrics and data management needs throughout the clinical development cycle.

Our focal points are:

Cardiology

Urology

Immunology

Gynecology

Diabetes

Oncology

Infections

Allergies

DMC Management

DATAN DMC management includes:

Independent data center services with statisticians and programmers and secure data storage/exchange
Function as a central point of contact for sponsors and IDMC members
Statistical services for interim analyses, e.g. for the re-estimation of the sample size and/or the premature termination of a study due to uselessness/effectiveness
Management of the process including contracts, compensation and meeting minutes
DATAN's biostatistics experts are ready to support your IDMC:
IDMC experience in a wide range of indications
Familiar with modern adaptive study designs including Bayesian designs
Communication and discussion of the results with medical experts
Presentation of results with modern BI tools
Ability to integrate all data sources from any EDC systems or other data providers

Clinical studies

DATAN has a strong focus on statistics for clinical trials and performs these specific tasks:

Planning of clinical studies (phases I-IV)
Assumption of the tasks of the audit and project statistician
Calculation of the sample size
Randomization (including emergency delivery)
Statistical programming in SAS® and R with SDTM and ADaM
Independent validation (e.g. source code review, double programming)
Interim analyses
Event time analyses

Professional expertise

DATAN has been a partner of for more than 35 years:

Pharmaceutical companies, from large to small and multinational to local companies
Biotech companies, from established to start-ups
Medical device company
Medical-aesthetic companies
Dietary and nutritional supplement company
Academic institutions

Regardless of the size and environment of your organization and projects, we take the time to understand your needs and challenges and share our experience and successes with you. In this way, we can help your development programs reach their full potential, make the right decisions based on the right data and deliver valuable products to patients quickly.