Specialist information processing services and business consulting for life sciences R&D organisations

Medical Writing Services

Kinapse offers a range of medical writing services at unmatched value. Services Clinical Development Plan: Write plans that define the clinical development objectives, approach, timelines and budget from phase one through to regulatory approval Clinical Study Reports: Coordinate write-up of full integrated clinical study reports and write specific sections of the full report using relevant information from the study protocol, statistical tables and listings, the Investigator Brochure, pertinent literature, medical monitoring reports, and selected patient case report forms Study related stand-alone documents: Write full documents or specific sections of the following: o o o Investigator brochures Informed consents Adverse event narratives

Clinical study report appendices: Write and compile appendices for clinical study reports. Clinical sections of the CTD: Prepare clinical sections of the CTD, i.e., Clinical Overview and Clinical Summary Clinical Sections of NDA: Write clinical sections of the NDA including Annotated Labelling, Integrated Summary of Safety, Integrated Summary of Efficacy, Application Summary, Human Pharmacokinetics and Bioavailability, Background and Overview, and Risk/Benefits

Other Writing services include: Preparing manuscripts and abstracts Writing and editing website text Writing Standard Operating Procedures

The Kinapse Approach We undertake both short-term and long-term engagements Each engagement team has a mix of delivery and client relationship personnel Delivery personnel are based in our Operations Delivery Centre (ODC) at Gurgaon, Delhi, India Client relationship responsibilities are managed jointly by delivery manager (offshore) and an onshore account manager Delivery is based on tightly-defined process mapping which enables enhancements to process efficiency over and above the factor cost advantages of the offshore centre

Specialist information processing services and business consulting for life sciences R&D organisations

Onshore personnel can be augmented if projects require a mix of onshore and offshore delivery

The Kinapse Advantage Specialist services for life sciences R&D organisations Proven and experienced team of R&D professionals Novel delivery model for highest quality services at unmatched value o o o Blended onshore-offshore teams Industry veteran Consulting Partners who bring experience and expertise Service Partners with distinctive, complementary services

Our rates are very competitive as we leverage the offshore delivery model. Rates are dependent on complexity of the assignment and length of contract.