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Quality Assurance Services ensures that all clinical studies/clinical trials conducted by Fortis Clinical research on behalf of our clients always accurately follow strict regulatory guidelines and global quality standards. Our team ensures that studies/trials are conducted based on up to date knowledge of local regulations. This is to ensure patient well-being is always protected and data integrity maintained.
Training services include in addition to meeting comprehensive training needs of in house personnel we help our clients achieve the level of expertise required through our high quality, user-friendly and cost-effective training programs - whether you need to train for a career in clinical trials, or update your knowledge with current programs.
Programs cover wide variety of clinical trials issues, viz. ICH GCP Principles; Regulatory affairs; clinical trial documentation; ethics; monitoring; project management; roles & responsibilities; quality assurance; audits & inspections; introduction to pharmacology; pharmacovigilance; bio equivalence & bio availability studies; data management; bio statistics; SAS; European, USFDA Schedule Y and other regulations; medical & scientific writing; investigator training, CRA/CRC training and several other trial issues.
We are a training partner to Cliniminds in conducting 6 months classroom Certificate program in Bioanalytical Techniques/LCMS MS - 3 month’s practical training to be given at FCRL.
Knowledgeable Quality Assurance Auditors.
All Quality assurance auditors are knowledgeable about local, national and international regulations, standards and guidelines. They have conducted quality assurance programs for preclinical and clinical studies throughout the world. Our QA staff comprises of qualified physicians, Masters/bachelors in pharmacy and PGD in clinical Research.
Variety of Quality Assurance Audits
In addition to a comprehensive internal clinical quality assurance program, our auditors provide clinical quality assurance audit services to our clients as part of a full-service or a standalone project. Our thorough assessment and insightful, objective recommendations help sponsors and sites develop the most effective actions to correct and prevent issues.
Among the clinical quality assurance audits we conduct are:
1. Project audits, e.g. investigator files, investigator site audits (We provide routine, directed, specialized and pre-inspection audits to help sites prepare for regulatory agency reviews), trial master file audits, database audits, statistical report audits, clinical study report audits and regulatory submission audits.
Review Method validation reports, instrument calibration and maintenance, sample analysis, raw data verification, in-process auditing, analytical report, personnel training and complete study reports of Bio equivalence Projects.
2. System audits in which we assess client standard operating procedures (SOPs), processes and staff training programs and recommend improvements where needed.
3. Vendor audits in which auditors evaluate a client's vendors to ensure they have sufficient capacity and capability to deliver quality products and services on time and in compliance with regulations.
In all cases, the Quality Assurance Services lead liaises with all relevant project stakeholders regarding any quality issues, study status and planning of audits. Following the audit, audit reports identify issues for the responsible parties to resolve at the project level. If broader, systematic issues are identified, plans to resolve these issues are operationalized too.
Finally, follow up is put in place for all issues with a corrective action plan, and all critical and major issues are followed to resolution.
Additional services include: |
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Perform in-life study audits, facility based audits and report/raw data audit to assess the facilities, equipment, procedures, methods, and documentation systems used in the generation of data are in compliance with systems and procedures defined in SOPs, protocol, regulatory guidelines and Quality manual/Quality policies. |
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Preclinical auditing services |
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Quality metrics for management reporting |
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Write and revise SOPs to ensure compliance with GLP/GCP as well as other implemented SOPs and policies. |
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Standalone auditing service, including investigator brochures, protocols and informed consent forms (and amendments) and regulatory submission documents |
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Review the Instrument qualification records, validation protocols of computer systems associated with equipments for acquisitions, processing and reporting of data. |
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Investigator meeting support, e.g. presentations on GCP, common audit findings and handling regulatory inspections at sites |
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Regulatory inspection support, e.g. hosting inspections or preparing investigator sites for inspections. |
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