CLINICAL TRIALS Since 2008 Adeodata has provided IT compliance support to clinical departments of pharmaceutical companies and also directly to CROs. In recent years, requests for compliance assessments and validation of computerized systems used in the clinical field have increased.
Requests have increased above all following the "Notice to sponsors on validation and qualification of computerized systems used in clinical trial" issued by the EMA on 7 April 2020.
Below, we report the regulatory references and guidelines on which we rely to set up the activities and some of the projects we have successfully conducted in the GCP field. REGULATORY REFERENCES AND GUIDELINES - FDA 21 CFR part 11, Electronic Records; Electronic Signatures
- ICH E (6) (R2) Good Clinical Practice
- EMA Q&A: Good clinical practice (GCP)
- EMA Notice to Sponsor on validation and qualification of computerized systems used in clinical trial
- GAMP Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data
GCP PROJECTS - Mapping of clinical data
- Governance / Policy setting for clinical validation (both for the Sponsor and for the CROs)
- System integrator audits
- Audit to SaaS system providers
- Management of contracts with vendors (verification of compliance and SLAs)
- Validation and maintenance of computerized systems (both Sponsor and CRO):
- validation of electronic TMF systems
- validation of CDMS (Clinical Data Managemet System)
- validation of IRT product distribution management (IMP) systems
- validation of SAS systems
- validation of systems for the generation and management of randomization lists
- validation of pharmacovigilance systems
- Training on the basic concepts of Computer System Validation, with a specific focus on the EMA's "Notice to sponsors on validation and qualification of computerized systems used in clinical trial" and on the validation of clinical systems (subject to GCP)
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