Even we will get to use your product someday. Enough reason for us to deliver.

Transcription

1 Even we will get to use your product someday. Enough reason for us to deliver.

2 ClinInvent: Putting our heart and soul behind the research. At ClinInvent, when we talk about clinical research it s not just another business terminology for us. It s a passion and belief that each one of us fosters within ourselves for improving human lives, through our area of expertise clinical research. Every member of our organization is aligned to our core objectives of precision, safety, commitment and excellence to ensure the marketability of our sponsor s products. As an end-to-end GCP compliant global Contract Research Organization (CRO), ClinInvent offers a complete suite of high quality, cost-efficient and user-friendly clinical research services to pharmaceutical, biotechnology and medical devices industries. Be it a single service engagement or complete management and co-ordination of entire clinical developmental program, we help our sponsors touch millions of lives by: Listening and aligning our team to their specific requirements Using appropriate processes to control costs and rapidly deliver research results Providing orderly, reliable and dependable data on time, every time ClinInvent Research, established in August 2003, is one of the few CROs in India with end-to-end capabilities in clinical trial management and data management. A part of The Chatterjee Group Lifesciences (TCGLS) initiative, ClinInvent is headquartered in Mumbai (India), with intellectual presence and investigator network across the country. ClinInvent s strength also lies in the fact that it has the opportunity to leverage TCGLS knowledge repository in drug discovery research and development areas through its business entities: Chembiotek Research International The Center for Genomic Application Silicogene Informatics Before the results satisfy you, it has to satisfy us. The group has also set up Institute of Molecular Medicine (IMM), a not-for-profit entity to pursue basic research in the field of clinical and phramacogenomics. Ethical clinical research practices. Delivered.

3 ClinInvent Services: Synchronized to our sponsor s objectives. ClinInvent prides itself in providing services that transcend borders and exceeds our sponsor s expectations on end results that are considered delivered, from the very first instance of our engagement. What drives us at ClinInvent is the unflinching commitment to the success of each client program. Every effort is made with an eye for detail, to ensure an implicit understanding of the sponsor's objectives. To transform R&D ideas into viable products for the market, ClinInvent delivers a complete bouquet of services that cover Phase I, II, III management and post marketing surveillance of clinical trials. The core services offered are: Clinical Operations Total project management Site Feasibility studies Regulatory and Ethics committee submissions Monitoring (Site initiation to study close out ) Investigator selection Financial contract management Management of drug supplies Clinical Data Management and Statistics CRF development Clinical Data Management Project plan (Data Management Plan, Data Validation Plan, Data Entry Guidelines) Database set-up and validation SAS Programming Data Entry, verification and validation Coding in MedDRA Writing Statistical Analysis Plan Randomization Performing interim and final analyses Statistical report writing Other specialized services offered are: Pharmacovigilance Medical Writing Quality Assurance GCP Training Before you engage us, decide on your launch date. Clinical development services from thought to finish. Delivered.

4 ClinInvent People: Stakeholders of our sponsor s goals. At ClinInvent nobody wears a nametag. We are a team who know each other s name by heart. This comes out of a deep mutual respect of our expertise, but more so from our consider it done attitude. Each member of the ClinInvent team is committed to understanding our sponsor s needs. With fewer levels of management and quicker decision-making capabilities, ClinInvent employs a team-driven approach to respond quickly to sponsor s requests. Thus ensuring action in the shortest possible time. Led by one of the visionaries of the life sciences industry, our clinical trial management team consists of GCP trained professionals from diverse academic backgrounds. A dedicated team of highly qualified and experienced clinical research professionals delivers multi-centric global clinical trial projects across several therapeutic areas. Every member of our team is an acknowledged specialist, with years of experience in managing quality clinical trials for New Chemical Entities (NCEs), biotechnology based products, vaccines, and herbal based pharmaceutical products, medical devices and other therapeutic drugs. Our Quality Assurance (QA) team is responsible for Standard Operating Procedures (SOPs) management, internal compliance of clinical team, training and systems and processes. The ClinInvent quality assurance department is independent of the clinical trial management team and is a custodian of the company s SOPs. The independent nature of the QA team guarantees the compliance and the quality of the audits. When you meet us, expect to meet your counterparts. Commitment for quality service, integrity and sensitivity. Delivered.

5 ClinInvent Operations: Custodians of our sponsor s mission. ClinInvent offers a fine mix of flexible clinical trial management services powered by cutting edge technology. Our work culture and expertise areas are one of trust and respect and are benchmarked against the best global practices in data management. Every day, the ClinInvent team touches base with the human face of science, across a myriad therapeutic areas. With a missionary zeal to constantly evolve, we continuously come up with innovative approaches and religiously get updated on the scientific advancements. Because we believe that when it comes to answerability, it s not just to our sponsor but our inner self too. We maintain a suite of full service CRO capabilities with a technology-based comprehensive database of qualified investigator sites, and collaborate with global sponsors in the US, Europe and Asia Pacific in several therapeutic areas: Cardiology Dermatology Hepatology Infectious diseases Nephrology Oncology Respiratory When you have pledged good health to the world, you are not alone. Innovative technology solutions and healthcare know-how. Delivered.

6 Mission To provide excellent clinical support services to pharmaceutical inventions by balancing the needs of quality, time and cost.

7 ClinInvent Research Pvt. Ltd. A-302, Everest Chambers, Next to Star TV office, Marol Naka, Andheri-Kurla road, Mumbai , India. Tel: , Fax: