Top–of–the–line medical documentation
     
  GVK BIO provides clinical research and data services for India-specific and global trials. In addition to trial operations management, medical monitoring, regulatory and quality assurance services, we also provide data management, biostatistics, medical writing and pharmacovigilance services to Indian and global clients.

We provide a full range of writing services for regulatory submissions and
medico-marketing materials across broad therapeutic areas for all the phases of drug development. Highly qualified communications and document specialists create the required documentation for our clients. An exclusive team of therapeutic experts with appropriate medical qualifications and a senior level biostatistician then review the documents.
 
 
  As part of document management, stringent security measures are in place to maintain data confidentiality. All documents created at GVK BIO conform to ICH-E3 guidelines and are finalized only after undergoing stringent peer review and quality control checks, followed by management reviews.  
 
Our service offerings include, but are not limited to:
Project management and writing Investigator Brochures
Protocol and Protocol Amendments, IND Annual Reports
Full and Abbreviated Clinical Study Reports
Patient Narratives
Clinical Trial Registry Synopses, manuscripts, abstracts, posters
and slide decks
The GVK BIO writing team has an average experience of five years in academic and regulatory writing. Our documentation experience includes number of peer-reviewed manuscripts, reviews and book chapters, US FDA submissions including one IND submission, Protocols, Final Study Reports, Investigator’s Brochure, and Patient Narratives.

These deliverables cover a wide spectrum of therapeutic areas, including oncology, obesity and diabetes, nephrology, infectious diseases and psychiatry. Our team has also written abstracts, manuscripts and study reports for a European sponsor.
 
Rajesh Kher, Ph. D.
  Over the last 15 years, Rajesh has authored several peer-reviewed publications, abstracts and posters, Investigator Brochures, final study reports, protocols and IND Annual Reports. He has received many awards during his career in academia and at Eli Lilly, USA.

He also holds a U.S. patent of a novel technique that identifies genes in situ. Rajesh received his Ph.D. in Endocrinology from S.G.P.G. Institute of Medical Sciences, India in 1995 and went on to do post-doctoral fellowships in Endocrinology at the prestigious Pritzker School of Medicine, University of Chicago, USA, and in
Nephrology at the IU School of Medicine, USA.

Later, he served as a faculty member in the Department of Medicine at IU School of Medicine, USA. Rajesh moved to Eli Lilly and Co., USA and worked in the Scientific Communications Division (Exploratory Program Medicine) as a senior medical
writer. Rajesh has been a member of many scientific societies including AMWA and SOCRA.
 
 
GVK BIO’s Key Differentiators
Knowledge of both, the US and Indian regulatory requirements, and experience in writing regulatory documents for FDA submissions  
Certificate training program in medical writing for external trainees
Pool of trained buffer associates for quick ramp up or to compensate for any attrition, hence, ensuring continuity in delivery
Outstanding scientific and therapeutic expertise for document review by experienced M.D.s
 
GVK BIO Medical Writing Services: Highlights
Authored and developed a Clinical Development Plan (CDP) for a US sponsor in less than three weeks  
Developed a CDP with international scope (trials in US and India) complying to regulations in both countries  
Documented successful full service Phase 3 studies with a Final Study Report for a European Sponsor that earned us repeat business with the client  
 
Please contact me on (484) 612- 2034 (USA) for any additional information that you may require. I look forward to hear from you.
 
Best Regards,
William O Brien
 
  www.gvkbio.com  
     
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