Clinical Data Management for Successful Clinical Trials
Clinical data management is one of the most essential elements of a successful clinical trial, serving as the backbone that ensures all collected data is reliable, accurate, and compliant with regulatory standards. This process is critical to your success because it directly impacts the credibility of your study’s findings and the likelihood of achieving regulatory approval. Effective data management mitigates risks, prevents costly delays, and enhances the overall quality of your clinical trial by meticulously handling data collection, validation, and analysis to maintain integrity and consistency throughout the study’s lifecycle.
QPS clinical data management services include:
- Development of clinical data management plans, data validation plans and data entry instructions based on your specific study design.
- Design of clinical database for clinical and external study data.
- Providing ready-to use forms.
- Providing training and 24/7 helpdesk.
- Data entry and validation.
- Data Coding
- Efficient and compliant data management throughout the conduct of the study.
- Data checks for consistency, validity and plausibility.
- Creation, assignment and maintenance of user accounts.
- Data extracts for further processing by the statistician.
- Compliance Outputs
- Consultancy and support in study design.
- Advice in study planning / sample size calculation.
- Development of the statistical analysis plan.
- Creation and development of randomization schedules, web-based randomization.
- Statistical programming with state-of-the-art software (SAS version 9.3).
- Interpretation, conclusion and reporting of data from a statistical perspective.
- Presentation of results (Interim Study Reports / Statistical Analysis Report).
- Publication and Presentation Material
Links to Relevant Documents
- Efficiently Performing Two Global Approval Studies in Prostate Cancer Patients
- Phase II-IV Clinical Overview
- Phase II-IV Clinical Services & Locations
- Early Phase Clinical Overview
- Expedited Study Delivery – Logistics
- Expedited Study Delivery – Pharmacy
- Studying Sedatives in Phase I Studies
- Pharmacokinetic Studies in Patients
- Corporate Overview Clinical Sites
Testimonials
Thank you very much for delivering the QC’ed data by timeline. It is great to work with you and your team.
LEI L.
Thank you again for the very nice draft report.
KAREN V.
Previous
Next