Effective planning comes down to having the right people in the right place at the right time.
Planning and managing clinical trials, of whatever size and complexity, requires efficient trial management.
CDMS and its partners offer excellent expertise in Study planning, Protocol Development and Submission, Clinical Site Activities, Data Management and Reporting with special focus on Non-Interventional Studies (NIS).
Study Planning
Study Planning
The in-depth knowledge of the local regulatory requirements and the network of investigators help to ensure that the trial objectives will be met on time and that costs will be kept within the budget.
Protocol Development and Submission
CDMS Regulatory Submissions network delivers a well-coordinated, collaborative approach that is critical to every phase of global trials.
Protocol Development and Submission
Our network structure ensures each Sponsor benefits from global expertise in every aspect, from writing informed consents, to translations, to working with regulatory authorities and ethics committees.
Clinical Site Activities
CDMS and CDMS-partners are well-versed in clinical trial operations including implementing, monitoring and managing the clinical components of a study.
Clinical Site Activities
From start-up to close-out, experienced clinical managers and clinical research associates (CRAs) oversee each study’s clinical processes to ensure proper planning, conduct, patient safety, and data quality, while fostering good communication between study sites and sponsor.
Data Management and Reporting
To serve our clients’ data management needs efficiently and cost effectively, CDMS has established a data management team.
Data Management and Reporting
We use validated software and computer systems compliant with ICH-GCP, EMEA and FDA standards.
In our network we can provide well established and user friendly eCRFs as well as hard copy CRFs