- Human Medicines, Biopharmaceuticals, …
- Service category
- GCP audit services, Regulatory services - CMC writing - medical writing, …
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- Audit / compliance service
- Clinical data service / data management
- Quality assurance
- Training / coaching
We offer 9+ years of experience in clinical operations working through all levels from CRA to head of department in CROs, big Pharma, small Start Ups, and in Biotech companies. During this time we could gather experience with studies in national and/or international setups, all clinical phases, pharmaceuticals, biosimilars, medical devices, and in various indications, respectively.
We provide excellent operational services within clinical project management including vendor selection and contracting (based on long-term relationships) or help with subtasks such as monitoring, submission to authorities, and maintenance of the trial file.
We also offer services for general clinical operations department tasks such as SOP writing, quality control systems, training of the clinical team, training documentation, development of study forms, documents, and manuals.
Quality is doing a job right the first time. The function of quality assurance (QA) is to detect deviations from accepted standards and weaknesses in order to improve systems, quality of work and cost-effectiveness.
CIS offers full services on quality assurance in clinical research and development. This includes regulatory-, monitoring- and biometric- QA support, for projects of phase I-IV, including post-marketing surveillance studies, but also development, review and consultancy for standard operating procedures (SOP) and vendor audits. CIS has also experiences in the auditing of data bases, electronic clinical trials, e-systems used (e.g., e-Data Capture, IVRS), central laboratories and GMP-aspects of clinical trials.
The primary goal of CIS is not just enumerate deficiencies but consult for improving systems and procedures in order to increase quality and streamline activities, therefore saving time and costs of projects. Recommendations for corrective and preventive actions is an integral part of our job. CIS is sensitive to the client's need for quality and cost-effectiveness and to provide the right service in the right time.
In contrast to many other auditors, we have practiced what we audit, knowing the problems of the auditees.
Quality Assurance - Services
CIS Clinical Investigation Support has a broad experience in conducting audits in all major areas of clinical research. CIS has performed audits in more than 30 different European and non-European countries such as e.g. Argentina, Austria, Australia, Belgium, Brazil, Canada, Denmark, France, Germany, India, Israel, Malaysia, Morocco, The Netherlands, New Zeeland, Portugal, Singapore, Spain, Sweden, Switzerland, Tunesia, Turkey, United Kingdom, United States, including also a large number of countries in Eastern Europe, such as Belarus, Bulgaria, Czech Republic, Croatia, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Russia, Slovakia, Slovenia, and Ukraine. CIS considers quality assurance services not only as an instrument to increase or maintain quality but also to reduce costs. CIS works with electronic forms on lap-tops to increase quality and speed.
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