Clinical Data
Management System

Clinion 

Clinion is a global clinical technology company that offers AI-enabled eClinical solutions. ClinionAI consists of EDC, RTSM, CTMS, eCOA and Document Automation that cover the entire clinical trial lifecycle. Clinion is committed to innovating the future of clinical trials through ClinionAI and empowering its partners to manage trials more efficiently at lesser costs. Clinion is head quartered in Hyderabad, India.

For more information, please visit  www.clinion.com

Medrio

Medrio is the leading provider of eClinical technology for pharma, biotech, device, diagnostics, and animal health clinical trials. Founded in 2005, the company’s cloud-based EDC, Direct Data Capture, eConsent, ePRO, and RTSM solutions deliver fast, flexible, and easy-to-use tools for the collection and management of clinical data and patient reported outcome responses. Study sponsors and contract research organizations have used Medrio extensively in clinical trials across a wide array of therapeutic areas, with notable success in oncology, infectious disease, and more. Medrio has extensive experience in all study phases and leads the market in early-phase trials. The company serves over 600 customers globally, with headquarters in San Francisco and offices in numerous domestic and international locations.

For more information, please visit www.medrio.com.

Castor

Castor is known for streamlining the clinical trial process with user-friendly and integrated tools. Key features include EDC, ePRO/eCOA, eConsent, robust reporting and analytics tools, and data integration via API and webhooks. Researchers can go live with studies in as little as 4 weeks and gain peace of mind with Castor’s first-class support teams.

Castor’s easy-to-use UI, comprehensive suite of integrated tools, and compliance with international data privacy and security standards are what separates Castor from the competition. Castor is scalable to accommodate different trial sizes, ranging from small pilot/feasibility studies to large phase III studies.

For more information, please visit  www.castoredc.com

Clinvigilant

ClinVigilant Reseach provides global clinical trials solution for Pharmaceutical, Medical Devices, Biotech, Neutracutical industries. ClinVigilant Research has developed digital enablement solutions, which can be used for decentralization and Hybrid clinical trials. Their digital solutions is scalable, cost effective and regulatory compliant. Clinvigilant has been audited by EMEA, MHRA, USFDA, DCGI authorities till date.

For more information, please visit  www.clinvigilant.com

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Shantanu Bagwe

Shantanu Bagwe

CA, Chief Financial Officer

Shantanu Bagwe is a Chartered Accountant (India) and MBA in Finance from UBI, Belgium with an experience of more than 10 years in Finance.

He has diversified Experience in Indirect Taxes and Foreign Trade Policy of more than a Decade. Eminent Speaker at Various Events of  ICAI (India), Trade Associations, Corporate Channels, Leading National TV Channels, etc.

Contributor of Publications in ICAI, Newspapers, etc and Group Member of Taxation Audits Quality Review Board (Indirect Taxes) of  ICAI.

Ramona Petrita

Ramona Petrita

B.Pharm, Chief Scientific Officer

Pharm. Ramona Petrita [F] ( Bachelor’s Degree in Pharmacy) is Clinical Research Professional with more than 15 years’ experience in Pharmaceutical Research Industry.

Ramona is currently leading the scientific and clinical operations at Ancillarie in Europe. She has skills in project management, strategic thinking and decision-making. She brings to the team is experience with developing strategic partnerships. This includes important networks with the pharmaceutical industry and medical organizations/societies, as well as with medical experts and healthcare authorities.

As Scientific Officer Ramona will provides professional leadership and expert clinical advice across the Organization by overseeing the scientific functions of companies and the design of clinical studies and associated research protocols. Moreover, Ramona is involved in several other roles: writing and reviewing scientific documents, coordinating research activities, designing and implementing objectives, managing performance, and reviewing and approving the standard operating procedures.

She has worked as Clinical Project Manager in an East European Contract Research Organization where she successfully coordinated more than 10 multinational clinical studies.

1668134826968

Kim McDonald-Taylor

MSc, CRPC
  • Kim McDonald-Taylor, MSc, CRPC is a Clinical Research Professional with more than 34 years of experience including her 12-year tenure with Endpoint Research holding positions such as VP Operations and Managing Director of Canada. She has worked in virtually every therapeutic area
  • Kim is providing technical guidance to Ancillarie in Canadian Clinical Operations . She operates a clinical consultancy, McDonald-Taylor Consulting, where her passion for her clients’ projects results in exceeded expectations for her training, project management, SOP creation, medical writing, teaching, meeting facilitation and strategic planning.
  • Kim received the Excellence in Clinical Research award in 2018 at the Canada Talks Pharma conference. Kim has volunteered with the Clinical Research Association of Canada (CRAC) ™ for the past 20 years.
  • Kim earned her MSc in toxicology from the Ontario Veterinary College at the University of Guelph. She has presented and co-chaired sessions at DIA, DIA Canada, ACRP and other meetings over the past 20 years
Amiit Keshav Naik

Amiit Keshav Naik

Founder and Chief Executive Officer

Amiit Keshav Naik (Graduate in Statistics, Post Graduate in Mathematics and Statistics, Executive Certificate in Entrepreneurship from Indian Institute of Management and Certified Graphologist ) is a Clinical Research Professional and his experience includes setting up Data Management & Biostatistics departments with managing team size of 250 professionals for various multinational CROs.

With more than 22 years of professional experience including 17 years of Professional Experience for top CROs; He has proven his strengths in Project Management which comprise of monitoring processes like Data Management, IVRS, SAS programming processes and External Vendors for more than 200 studies across different therapeutic areas.

He has provided his expertise to the Business Development team to develop proposals for Bid Defence Meetings. His strong leadership and communication skills facilitates diverse cross-functional teams to deliver positive results.

He has built reputation for efficiently meeting challenges in rapidly changing environments while consistently delivering excellence.

Amiit also has supported academia as visiting faculty for Data Management subject at a Pharmacy College. He has also worked as paper setter and examiner for Biostatistics and Data Management subjects for M.Sc. Pharmaceutical Medicine.

He has built reputation for efficiently meeting challenges in rapidly changing environments while consistently delivering excellence.

Amiit also has supported academia as visiting faculty for Data Management subject at a Pharmacy College. He has also worked as paper setter and examiner for Biostatistics and Data Management subjects for M.Sc. Pharmaceutical Medicine.

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Medrio

Medrio offers an eClinical Software as a Service (SaaS) application with an online Electronic Data Capture (EDC) system that doesn’t require any programming.

With 1300+ studies, 500+ customers, and a 98% satisfaction rate, Medrio provides simple, fast, and affordable tools for clinical trials, including a specialized product for Phase I.

For more details, please visit: www.medrio.com

Castor

Castor is an ISO 9001 and ISO 27001 certified, 21 CFR Part 11 validated, GDPR & HIPAA Compliant Electronic Data Capture (EDC) system.

Castor’s built-in EDC system makes it easier to deploy studies faster with following features :

For more details, please visit: www.castoredc.com

Clinion

Clinion is a 21 CFR Part 11 validated Electronic Data Capture (EDC)TM and Clinical Data Management (CDM) system.

Clinion is focused on reducing the new product time-to-market for Pharmaceutical, Biotech, and Medical Device Organizations by providing a highly configurable and user-friendly Clinical Trials Solution. Clinion is headquartered in Hyderabad, India.

For more details please visit: www.clinion.com

Clinvigilant

Clinvigilant is an ICH-GCP, GDPR & 21 CFR Part 11 compliant complete configurable Electronic Data Capture (EDC) system. With in-depth knowledge in wide range of industries and expertise they provide easier, faster tools for clinical trials. Clinvigilant has been audited by EMEA, MHRA, USFDA, DCGI authorities till date.

For more details visit: www.clinvigilant.com

Statistical Consulting

Our partnering company based in Germany gives us an edge to connect more effectively to our clients based in Europe.

With help of our partners we provide Statistical Analysis, Consulting, programming and Writing services for our clients based in Europe and rest of world.

For more details please emails us on: contact@ancillarie.com

Phase I and Bioequivalence

Our partner is a state of the art hospital certified Medical Centre based in Montreal, Canada. The facility was recently accredited with exemplary standing by Accreditation Canada.

For more details please email us on: contact@ancillarie.com

Clinical Operations

Our partnering companies based in Buenos Aires- argentina, North Carolina-United States of America are oriented to provide advice, assessment, support and recommendations to pharmaceutical, biotechnology, Medical Device industries and Contract Research Organizations as well as other companies that actively work in different stages of Clinical Trial Development.

For more details please email us on: contact@ancillarie.com

Dr. Suresh K Bowalekar

Ph.D., C.Stat.(UK), C.Sci.(UK)

Dr. Suresh K Bowalekar has more than 35 years of experience in the field of Clinical Research and Biostatistics. He retired as the Managing Director of PharmaNet, India in August, 2012.

His able leadership was responsible for systematic growth of PharmaNet at 2 locations in India – Bangalore and Mumbai, within a span of initial 3 years since its inception in 2003.

Dr. Bowalekar, the Fellow of Royal Statistical Society (FSS), London was honoured by various esteemed institutions as follows:

  • Chartered Statistician (C.Stat.) – the highest credentials in statistics in 1993, jointly by the Royal Statistical Society, London and Institute of Statisticians, U.K.
  • Chartered Statistician (C.Sci.) by The Science Council, UK, 2009.
  • Recipient of “Indira Gandhi Sadbhavana Award” for 2005.
  • His name is included in 2007-2008 edition of International WHO’S – WHO directory of professional.

At the initial span of his career, he spent couple of years in teaching. Post that he spent almost;

  • 10 years in banking and economic statistics with Econometric Department of the prime bank of India – Reserve Bank of India.
  • 11 years in Pharma MNC Searle India Ltd.
  • 11 years in the top management team of Wockhardt Ltd.
  • 3 years in Quintiles – a Global CRO, he established DM & Biostatistics Unit in India.
  • Retired as Managing Director, of PharmaNet/i3, India after serving it for almost a decade.

His two books – “Basic Statistics for Chemist” and “Handbook on Operations Research” are due for publications. He has about 90 research papers and more than 100 presentations to his credit. He has been contributing to the success of CRO industries and participating in continuous progress in scientific thought process by serving following associations in various capacities like;

  • General Secretary of ISCR (Indian Society for Clinical Research)
  • Appointed Member of BoT (Board of Trustees) Of SCDM
  • Member of Governing Council of IASCT (Indian Association for Statistics in Clinical Trials)

He is a guide for Ph. D. Students of Yashwantrao Chavan Maharashtra Open University (YCMOU) Nasik, Maharashtra, India. He has served as the member of various committees set up by the Drugs Controller General of India to prepare:

  • Guidelines on Bioequivalence studies for immediate release
  • Guidelines on Bioequivalence studies for modified release drugs
  • Good Clinical Trial Regulations in India (GCTRI).

Dr. Jack Green

 Ph.D.

Dr. Jack Green has held senior-level positions for more than 30 years in both Pharmaceutical as well as Contract Research Industries.

He was one of the founder member of PharmaNet, as Senior Vice President of Biostatistics and Data Management.

He was also associated with Covance as Senior Vice President of Biostatistics and Data Management, at Adria Laboratories as Director of Biostatistics and at Merrell-National Labs as Senior Biostatistician.

Dr. Jack Green has extensive experience in setting up and managing global operations in Biostatistics, Statistical Programming, Data Management, IT strategies and Interactive Technologies.