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Outsourcing Medical Writing
to India

chillibreeze writer — Sapna Gore

Clinical data management is an important component for reporting clinical trials. It involves the collection, handling, analysis and cleaning of data to ensure that the quality is acceptable for submission to the regulatory authorities. In the past, data management would begin with the submission, but now, due to stringent quality requirements, data management plays an important role right from the preparation of the protocol to the data lock and study closeout.

Technological advances affecting data management: A large amount of paperwork involved in data management is being eliminated. This task is accomplished by remote data entry and lab-reports that are stored in an electronic form. Video and Internet conferencing facilities have made data management possible in any part of the world. All CROs and pharmaceutical companies are coming forward to develop a global data management system to simplify data exchange processes.

Why outsource? Clinical research activities are growing rapidly. The cost of developing a new drug is approximately $800 million. More than half of this is spent on clinical trials. Outsourcing has become the best option for the speedy approval of drugs. According to a study conducted on the CRO market by UBS Warburg(2001), “A growing percentage of outsourced pharmaceutical R&D and higher biotech demand is expected to drive the CRO sector growth ahead of the 10% or 12% norm.”

Clinical research activity in India has grown tremendously over the last decade. The IT boom in India has paved the way for several other emerging fields; one among them being clinical research. India’s highly qualified labor pool, technological innovations, cost effectiveness, high quality work and operational flexibility has made it one of the most preferred outsourcing destinations in the world.

We at Chillibreeze provide you with quality clinical research documentation services. Our team of experts from the field of medicine and pharmacy has vast experience in conducting clinical trials.

Our services have been trendsetters when it comes to-

1. Standards: Our documentation conforms to international standards.
2. Timeliness: Deadlines are always adhered to, thus facilitating faster drug development process.
3. Confidentiality: Chillibreeze enjoys the trust of its many customers. It has stringent, foolproof security processes in place to handle valuable customer data.
4. Competitive pricing: Chillibreeze is offering attractive tariff plans for a host of its services.

We provide systematic data management plans by deploying the appropriate software. We also perform consistency checks and query generation. Our motto is to provide consistent, accurate and valid data to our customers enabling speedier trial results, faster registration and thus rapid marketing of the product.

Our services include:

1. Investigator brochure preparation
2. Protocol design
3. Preparation of CRF
4. Interim and final study report
5. Cleaning data for regulatory submissions
6. FDA briefing documents

Do contact us with for your clinical research documentation requirements.

Out of 5 “chilies”, our editorial team gave this article...

 

Out of 5 “chilies”, our editorial team gave this article...

 

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—About our writer: Sapna writes for chillibreeze.

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