If you thought we are all about excellence in clinical trial and data management, we would like to share with you our "other" services that transcend classical clinical research solutions. We believe the services that we bring to our sponsors should encompass all the components that a successful clinical trial requires. Be it pharmacovigilance, quality assurance or even GCP training. This ensures synergies between varied services, which helps deliver solutions that our sponsors expect from us.

Take a look at what we have to offer.

Pharmacovigilance encompasses surveillance of adverse events after short-term and long-term use of medicines. We offer the following services on safety reporting:

• Dedicated persons and fax line to receive reports of SAEs at all times
• SAE collection, evaluation and classification
• SAE reporting as per sponsor's guidelines and safety related information
• Regular monitoring and reporting within international reporting time frames
• Follow-up with the sites and preparation of summary reports for onward submission to sponsor, ethics committee, regulatory bodies locally
• Addressing safety issues in a comprehensive and accurate manner

We have trained scientific and medical professionals with expertise in preparation of all documentation needed throughout the drug development process, in accordance with ICH guidelines and regulations. The highlights are:

• Protocol development
• Investigator brochure
• Informed consent form
• Clinical study reports
• Manuscript for publications

Our Clinical Quality Assurance (CQA) system ensures GCP compliance for every phase of trial. ClinInvent has successfully faced audits from global sponsors and CROs. The Quality Assurance team is responsible for SOP management, internal compliance of clinical team, training, systems and processes. Quality Assurance Department is independent of the clinical trial team and a custodian of company's SOPs. The independent nature of the CQA team guarantees quality of the compliance auditing. The services offered are:

• Site audits
• Vendor audits
• Data audits/Database audits
• System audit
• In-house audits
• Ethics committee audit

GCP Training is one of our core strengths. Besides conducting rigorous internal training, the senior management team of ClinInvent offers GCP training to clinical research professionals of Pharmaceutical companies, CROs, etc., and are invited as faculty in clinical research related seminars and workshops in India. Our team has provided GCP training to staff of several CROs and multinational pharma companies. The highlights of the program are:

• Customised program catering to the training needs for GCP of all clinical research professionals
• Training program with extensive theory and practical examples
• Advanced GCP training based on case studies
• Site training in practical aspects of study management