The current Good Clinical Practices (cGCP) have their origin in 1964, wherein the 18th World Medical Association Annual General Assembly voted to adopt the Declaration of Helsinki. The primary objective of the Declaration of Helsinki is assuring the safety and wellbeing of each medical trial subject. Since that 1964 adoption vote, the cGCPs have been harmonized, globally required by Regulatory Bodies, and the America Association of Medical Assistants (AAMA).
A successful Clinical Trial must ensure the data integrity of the trial results. To do so requires the design and implementation of a compliant cGCP QMS. Inadequate cGCP QMS design and implementation are the leading cause of Regulatory Agencies rejecting Clinical Trial Reports due to lose of data integrity. As a result, GCP Consultants, FDA Compliance Consultants, and FDA Compliance Training, have become a vital key component for successful Clinical Trials.
Clinical Trial Investigators are the central hub of the Clinical Trial Environment. They must assure compliance with every element of the cGCPs and the Trial Protocol. Successful Investigators have learned to utilize GCP Consultants, FDA Compliance Consultants, and FDA Compliance Training,
Competent GCP Consultants, FDA Compliance Consultants, and FDA Compliance Training will:
- guide the proactive effective, efficient, and compliant design and implementation of any cGCP QMS and compliant execution of the Clinical Trial Protocol.
- proactively identify and guide the remediation of any deficiencies in the Required Elements of the cGCPs and the cGCP QMS.
- maximize the Integrity of your Clinical Trial Protocol Data by guiding the Investigator, Sponsors, IRBs, and Trial Team Members on the full spectrum of their roles and responsibilities and how their actions impact compliance with the Data Integrity Requirements.
- proactively guide the compilation and structure of all Clinical Trial Subject Case Reports, other Reports, and Final Trial Reports.
The three phases of Clinical Trials are costly and time consuming for a plethora of reasons. Phases 1 and 2 focus on safety and efficacy. Phase 3 Trials are larger, the most expensive, and expansive to identify overall risks, and occurrence of potential adverse events. All Clinical Trials require consistency across cGMP Clinical Trial Materials, Trial Protocol content, and implementation via adherence to cGCPs.
Sponsors, Investigators, and Trial Site Institutions protect their Clinical Trial Investments via their proactive utilization of GCP Consultants, FDA Compliance Consultants, and FDA Compliance Training.
William E. Spanogle, Ph.D. has over 30 years of management, full spectrum Regulated Life Sciences, RA, QA (GCP, GLP. GMP), EU-MDR, QMS, PMS, CSV/CSA, and R&D experience. He is a published ISPE Invitational author in Pharmaceutical and Biologics Product and Process Development and has presented and trained thousands of professionals on QbD, Design Controls, Science-Risk Based Product Characterization, and Risk Management at several international conferences and numerous private corporate sessions. Dr. Spanogle has taken scores of Regulated Life Science Products from discovery to pre-clinical and clinical trials, to approval and launch; and audited, identified, and remediated QMS deficiencies.
The opinions and statements in this blog are those of the authors and do not necessarily reflect those of BRG. This blog is based on personal experience and reviews of information publicly available or identified in other database searches.
tagging: cGMP Clinical Trial Investigator