Quality & Compliance

Clinical trials are conducted to collect the data necessary to provide information for an investigating drug to reach the market. To ensure investigators are following the protocol, complying with regulatory and Good Clinical Practice (GCP) standards, and collecting and reporting quality data, sponsors of clinical trials monitor the progress of clinical trials performed by the investigators during the clinical trial. Quality and compliance assurance services help the clients to ensure the integrity of their clinical trials. In addition to providing in-house quality assurance auditing for clinical trial sites, CROs and third party vendors, we help clients to protect research subjects’ rights and welfare, verify the integrity of data and ensure adherence to protocols and international regulatory guidelines. Pharmaceutical organization which provides ICH GCP investigator training and clinical compliance certified by the regulatory agencies. Their GCP training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by Trans Celerate BioPharma as necessary to enable mutual recognition of GCP training among trial Sponsors. Some crucial quality and compliance services for clinical trials are- Vendor audits, assessments and qualifications, including GDP depot audits, in which we evaluate a client’s vendors to ensure they have sufficient capacity and capability to deliver quality based services on time and in compliance with regulations, Clinical investigator site audits (Phase I/Bioequivalence facilities and clinical trials, Phase II-III clinical trials, post-marketing activities, routine, for-cause and pre-inspection audits to help sites prepare for regulatory agency reviews, Clinical study document audits and reviews, Clinical investigator site compliance visits, GCP and GVP quality system audits, in which we assess client internal processes, standard operating procedures (SOPs), staff training programs, as well as provide recommendations for improvement, Safety surveillance/pharmacovigilance audits. To maintain the compliance of clinical trials companies follow the following points of quality, Creating, implementing, and upholding standard operating procedures (SOPs) for trial execution, A quality scientific and medical design of the protocol, Clinical investigator and site pre-assessment and selection, Regulatory agency and ethics committee approval, Developing and providing appropriate informed consent (language, transparency of benefits and risks) and obtaining ethics committee approval of the informed consent process, Investigator meetings and training, Adequate recording and reporting of data, Periodic monitoring, timely audits. The Clinical Study Report (CSR) is the report that summarizes the clinical data. It includes the entire protocol, sample case report forms, investigator information, all information related to the investigational product being studied as well as any statistical analyses, publications, tables or other data. It is an integrated report that contains all study related information and is provided to regulators, after conclusion of every study. In the CSR, questionable data is typically removed from the efficacy portion of the study analysis, to ensure that such analysis is reliable, and the report will explain why this data was excluded. The data may still be used for safety analyses. In some instances the study analysis is performed with and without the questionable data to provide the regulators with both results for consideration. Transparency of both the data, and the processes for analyzing the data is essential for regulators to understand the ethical conduct of the trial.