Nimita Limaye - Freelance Clinical Trials Consultant in Massachusetts, United States

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Profile Summary

Industry leader with 20+ years of expertise in the clinical trial, drug development space. PhD Biotech, Adv Dip French Literature. Have represented my organizations as a thought leader and a spokesperson in key global forums. Running my own consulting company. Have over 30 publications to my credit and have served on the Editorial Board of the Journal of Applied and Translational Genomics. Areas of expertise - risk based monitoring, CDM, medical writing, programming, clinical operations, pharmcogenomics, oncology, biomarkers, data integrity, standards, regulatory, disruptive innovation, wearables, writing research articles, reviews. We have also provided website designing and content development services for genomics companies, and biopharma.

Publications
1. Limaye N. Data Integrity – It’s really about your integrity! (May 2016) Pharma Times, 48.5, 17-18.
2. Limaye N and Saraogi A. Leveraging Social Media in Pharma and Healthcare: The Past, the Present and the
Future. To be published
3. Limaye N. Pain Points and Evolving Outsourcing Needs: Clinical Data Management Revisited. (Fall 2015)
Data Basics, 21.3, 13- 14.
4. Limaye N. and Carol IB. The Modern Social Contract between the Patient, the Healthcare Provider and Digital
Medicine. (2014) J Socialomics, 3:1. (This paper was cited by Eric Topol, Director, Scripps Transalational
Science Institute, in his book titled ‘The Patient will see you Now’.
5. Limaye N. Pharmacogenomics, Theranostics and Personalized Medicine – The complexities of clinical trials:
Implementation in the developing world – this is it.... Applied and Translational Genomics (2013),
http://dx.doi.org/10.10.16/j.atg.2013.05.002
6. Whitsell R, Pu F and Limaye N. The Outsourcing and Offshoring of Medical Writing – a Comprehensive
Approach. (2013) DIA Global Forum, 5.5, 43 – 48.
7. Kumar N, Limaye N. Implementation of Regulatory Controls in the Life Sciences Industry. (2013) DIA
Global Forum, 5.4, 58 - 63.
8. Limaye N. Key Success Factors for Establishing Strategic Partnerships in CDM, BSP and Medical Writing –
India as a Key Destination. (2012) TCS Gartner Compendium on Strategic Partnerships in Drug Development
and Drug Safety, 8 – 10.
9. Clemow D, Gawrylewski G and Limaye N. The Core Competencies of a Medical Writer: Should a Medical
Writer be Medically Qualified. (2012) TCS Gartner Compendium on Strategic Partnerships in Drug
Development and Drug Safety, 14 – 17.
10. My interview has been published as a chapter in a book, ‘How India found its feet: The story of Indian
Business Leadership and Value Creation’, where interviews of 14 business leaders are being published. Prof
A. Agrawal
11. My interview was published as an Outstanding Women Leader in Tanishka, a local publication in Sep’12
12. Limaye, N. Driving change in CDM: A vision for the future. A thought leadership article released at the
SCDM AC, Sep’12 by TCS.
13. Goulikar, D. and Limaye, N. 2012 Fall. Technology Drivers for CDM. Data Basics, 18.3, 20-22.
14. Limaye, N. Strategic Partnerships between Sponsors and Vendors. Data Basics, 18.2, pg 3- 4.
15. Limaye, N. The Importance of Medical Writing. Pharma BioWorld, 10.6, Jan,11.
16. L. Venkatraman, Limaye, N., Battisiti, W. and Glasser, S. Manuscript vs Regulatory Writing: The Key
Differentiators. DIA 6th Annual Magazine, India, 2011.
17. Limaye, N. Offshoring Opportunities (listed in editor’s choice), EPC, Mar 2011.
18. Limaye, N. “Pharmacogenomics and Metabolomics”. Data Basics, 16.4, pg 6 – 8, Winter, 2010.
19. Limaye, N. “Personalizing Bioinformatics”. PharmaAsia, Sep, 2010.
20. Limaye, N. ‘‘The Outsourcing of Medical Writing: The evolution of a niche domain”, Pharma Times, Aug
2010.
21. Limaye, N. ‘Data Management Redefined’, PICR, Oct 2010.
22. Efficiency in Clinical Study Report Writing. Gawrylewski. H, Sokol. P, Limaye, N. Shetty. N, and Tatke, A.
Presented by Gawrylewski. H at AMWA, Milwaukee, WI in November ‘10.
23. Venkatraman L., Limaye N., Glasser, S, Battisti, W. A survey of adherence to the Consolidated Standards of
Reporting Trials (CONSORT) guidelines for abstracts. 2010. This poster has been presented at the 6th Annual
Meeting of ISMPP, April ‘10, at Arlington, Virgiinia.by Lakshmi V and JnJ couterparts.
24. Limaye, N. Planning for Clinical Data Management Projects. Data Basics14.1, Spring 2008, 7 and 17.
25. Limaye. N. Career development in clinical data management. Data Basics14, 2, Summer 2008, 20.
26. Limaye,.N. 2007 Winter, The changing role of the clinical data manager. Data Basics (an SCDM publication),
13.4, 18.
27. Choudhary, P., Kumar, N.N., & Deobagkar, D.N., The glucanases of Cellulomonas. 1997 Biotechnol.Adv.
15, 315-331.
28. Kumar, N.N., & Deobagkar, D.N., Multifunctional Glucanases. 1996 Biotechnol.Adv. 14, 1-15.
29. Kumar, N.N., & Deobagkar, D.N., Presence of multiple amylases encoded by independent genes in
Cellulomonas sp. NCIM 2353. Biotechnol. Lett. 17, 797-802.
30. Kumar, N.N., & Deobagkar,D.N., Expression and characterization of amylase encoded by a gene cloned from
Cellulomonas sp. NCIM 2353. World Journal of Microbiol. and Biotechnol, 13, 491-496.
31. Kumar, N.N., Bhide, A., Gokhale, D.V., & Deobagkar, D.N. 1995, Production of extracellular amylase by
Cellulomonas sp. NCIM 2353, Biotechnol.Appl.Biochem, 22, 345-353.

Subject Matter Expertise

Services

Writing
Research

Writing Clinical Trial Documentation, Technical Writing, Newswriting

Research Gray Literature Search, Systematic Literature Review, Secondary Data Collection

Work Experience

CEO

Nymro Clinical Consulting Services

October 2016 - Present

CEO & Principal Consultant

Nymro Clinical Consulting Services

October 2016 - Present

VP, Lead, Data Driven Trial Execution , GDN

Quintiles

February 2016 - September 2016

VP Risk Based Monitoring

Quintiles

January 2016 - September 2016

Head, Healthcare BPS Offerings, Analytics and Clinical CoE

Tata Consultancy Services Ltd

June 2012 - January 2016

Sr. VP and Global Head, CDM, Medical Writing and SCEDAM (Strategic Centre of Excellence for Data Management, Analytics and Medical Writing

SIRO Clinpharm Pvt Ltd

January 2006 - June 2012

Sr. VP & Global H, CDM, MW and Strategic Centre of Excellence for Data, Analysis & Medical Writing

SIRO Clinpharm Pvt Ltd

January 2006 - June 2012

Medical Documentalist

Altana Pharma Healthcare Pvt. Ltd

July 2003 - December 2005

Associate Regulatory Affairs and Training, Associate Drug Safety, Clinical Data Coordinator

Quintiles Inc

April 2000 - June 2003

Education

PhD (Biotechnology)

University of Pune

1992 - 1996

University of Pune

Doctor of Philisophy (Ph.D) - Biotechnology

January 1989 - January 1995

Certifications

Certification details not provided.