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CDISC Implementation

& mapping

CDISC data standards are highly recommended by the FDA for Submission. These standards are now adopted in various phases of clinical research by industries. With our experience, we can help your company make data standards implementation and migration unified. We currently follow STDMIG 3.1.2 to STDMIG 3.1.3 and ADaMIG 1.0.

  • CDISC compliant Case Report Form
  • CDASH annotated Case Report Form
  • SDTM annotated Case Report Form
  • Trial design compliant Dataset
  • SDTM compliant Dataset
  • ADaM compliant Dataset
  • Generation of Define.xml, rtf and pdf
  • ADaM metadata
  • Utilization of Open CDISC

CDISC data standards specify how to structure clinical trial data for regulatory submissions to the US Food & Drug Administration (FDA). They are widely used during the analysis, reporting and the regulatory submission of clinical data. 

We specialize in CDISC implementation and data mapping services to ensure compliance with industry standards and facilitate the exchange of clinical trial data across different systems and organizations. Our expert team can help you navigate the complexities of CDISC standards and streamline your data management processes. By implementing CDISC standards and ensuring data mapping adherence, you can streamline data exchange, improve data quality, and facilitate regulatory submissions.

Contact us today to discuss how our CDISC implementation and data mapping services can optimize your data management processes.

  • CDISC Standards Expertise
  • CDISC Compliance Assessment
  • CDISC Implementation Planning
  • CDISC Data Mapping
  • CDISC Metadata Management
  • CDISC Compliance Documentation

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Canada

Ancillarie,
500-1450 Meyerside Drive, Mississauga, ON L5T 2N5, Canada.

India

 DBS Business Center, ‘B’ Wing, Ground Floor, Kanakia Wall Street, Andheri – Kurla Rd, Chakala,Hanuman Nagar, Andheri-East,
Mumbai-400 093, Maharashtra.
India

Armenia

 Avan, Duryan 1st str. 10, Yerevan, Armenia.

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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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Insights 2023

  • Ancillarie signed CDAs with 5 EDC vendors and 1 Business Development Consulting Group
  • Ancillarie initiated providing 1 additional service for Clinical Operations
  • Ancillarie marked a significant milestone as it celebrated its 11th-year anniversary. With over a decade of dedication and innovation, Ancillarie continues to thrive, demonstrating resilience and excellence in its industry- Nov 2023.
  • Ancillarie successfully executed a Confidentiality Disclosure Agreement (CDA) with an Indian CRO providing pre-clinical services- Oct 2023.
  • Ancillarie efficiently welcomed and onboarded two new team members for the Data Management department- Oct 2023.
  • A Confidentiality Disclosure Agreement (CDA) has been successfully executed with one Indian Statistical Consultant group and another with a German-based Statistical Consultant group, affirming our commitment to secure and confidential collaborations with these esteemed partners- Oct 2023.
  • We are thrilled to share that we've inked a contract with a leading US-based ophthalmology company for clinical data management work. This strategic partnership marks a key milestone in advancing our collaborative efforts in the field- Sep 2023.
  • Team Ancillarie came together in joyful celebration, expressing heartfelt gratitude and appreciation for the dedicated service of two of our esteemed members who marked their 1st work anniversary- Aug 2023.
  • We are pleased to announce the successful onboarding of our new Vice-President and head of Data Management for the UK region. This strategic addition to our team reinforces our commitment to effective data management practices to help to grow in UK- Aug 2023.
  • Ancillarie team provided Demonstration on Data visualization and automated manual review for USA based pharmaceutical company.
  • Ancillarie has signed CDA’s with 2 Indian Contract Research Organizations and 1 with Statistical services consulting group based in USA for complementing various services provided in Clinical research.
  • Our Founder & CEO Mr Amiit Naik received at invitation from Embassy of Italy to attend ‘Invest in Italy’ Forum held on 28 Jun 2023 at St. Regis Hotel, Mumbai. A informative, engaging, and enriching conference.
  • Ancillarie attending Phuse Single Day Event on 17th June 2023 at Ahmedabad. A platform for gaining valuable insights and knowing the latest industry trends Our Founder & CEO Mr Amiit Naik was invited to an ‘Exclusive CXO Roundtable’ on 22 June 2023 at Sofitel BKC, Mumbai.
  • Ancillarie effectively initiated vendor audit for an EDC (Electronic Data Capture) vendor.
  • We are delighted to confirm the successful implementation of our new HR software, a significant advancement in improving organizational efficiency and streamlining human resource processes, paving the way for a more streamlined and efficient HR workflow.
  • Ancillarie was one of the exhibitors at Pharma Regulatory Annual Summit 2023 held at Hotel Kohinoor Continental, Mumbai in March 2023
  • The ACDM conference for the current year 2023 was held at Barcelona, Spain on 13th March and 14th March, 2023. Ancillarie was the Exhibitor from India and Day 1 Sponsor.
  • Ancillarie has sponsored the event organized by NGO Being Social-Ek Naye Shuruaat. Being Social-Ek Naye Shuruaat has provided a platform for support underprivileged children to showcase their talents in January 2023

Insights 2022

  • Ancillarie became an ISO 9001:2015 Certified Company in November 2022.
  • Ancillarie successfully celebrated 10 years, a memorable event was held at Hotel Kohinoor Continental, Mumbai to celebrate the achievements for our 10 year anniversary.

Insights 2020-2021

  • Successfully completed of Dermatology trial, by providing Clinical Data Management, Biostatistics, Statistical Programming, Medical Writing services and supported client in e-submission activities for US FDA
  • Became official sponsor for Medrio organized m-squared conference in California, USA
  • Awarded with 2 Diabetic and 1 Infectious study for Biostatistics and Statistical Programming
  • Successfully completed 1st internship batch in Human Resource and Biostatistics department
  • Ancillarie India changed its entity status, from Ancillarie partnership company to Ancillarie Limited Liability Partnership (LLP)
  • Ancillarie Successfully passed audit conducted by UK based global CRO

Insights 2018-2019

  • CDA signed with USA based Business Development Consulting firm in- April 2019.
  • CDA signed with Clindox one of the preffered EDC vendor for Ancillarie in- March 2019.
  • CDA Signed with Russian based CRO for Clinical Data Services work in- March 2019.
  • CDA signed with 3 USA based CRO for Clinical Data Services work in- October and November 2018.
  • CDA signed with South African based CRO for Clincial Data Services work in- September 2018.
  • CDA signed with ACS EDC one of the preffered EDC vendor for Ancillarie in- July 2018.
  • CDA signed with DSG EDC one of the preffered EDC vendor for Ancillarie in- May2018.
  • CDA signed with USA based CRO for Clinical Data Services work in- February 2018

Insights 2016-2017

  • CDA signed with 1 USA based CRO, 2 Canadian CRO, 1 Russian based CRO for Clinical Data Services work in- November and December 2017.
  • CDA signed with Indian CRO for Clinical Data services work in- November 2017.
  • CDA signed with USA based CRO for Statistical Programming work in- November 2017.
  • CDA signed with German CRO for Clinical Data Management work in- October 2017.
  • Change in status of Legal entity in India, from Ancillarie partnership company to Ancillarie Limited Liability Partnership(LLP) company- September 2017.
  • Change in status of Legal entity in India, from Ancillarie partnership company to Ancillarie Limited Liability Partnership(LLP) company- September 2017.
  • Successful completion of First internship batch in Human Resource and Biostatistics department- August 2017.
  • CDA signed with USA based Statistical Consulting firm for Clinical Data Services work in- July 2017.
  • CDA signed with 2 Indian CRO for Clinical Data services work in- June 2017.
  • Ancillarie awarded with two Diabetic and one Infectious study to perform Biostatistics and Statistical Programming work by United Kingdom and Middle East client- April 2017.
  • CDA signed with European based CRO for Clincial Data Services work in- March 2017.
  • Ancillarie Mumbai office successfully passed audit conducted by United Kingdom based global CRO- March 2017.
  • Ancillarie was official sponsor for m-squared conference organized by Medrio in California, USA. http://medrio.com/m_squared/agenda -March 2017.
  • CDA signed with Latin American CRO for Clincial Data Services work in- January 2017.
  • Ancillarie successfully completed Data Management, Biostatistics, Statistical Programming, and Medical Writing activities for 2600 patients (140400 pages) generic study in Dermatology Therapy. Also supported client in e-submission activities USA FDA-January 2017.
  • Programming work in- December 2016.
  • Ancillarie added two more services under their portfolio Pharmacovigilance and Resourcing – December 2016
  • CDA signed with Danish CRO for Clinical Data Services work in- November 2016.
  • Press Release: Medrio and Ancillarie Publish First-Hand Data Manager Accounts of Using Medrio’s EDC Software. EIN News – October 2016
  • Case study by Medrio and Ancillarie: At Ancillarie, Medrio Makes Study Build Easy, Even for New Data Managers – October 2016
  • Ancillarie’s new office located in Mumbai, India was inaugurated on 01st April 2016, by ancillaries’ advisory board member Dr. Suresh K Bowalekar and founder of Adam Fabriwerk Pvt. Ltd. Mr. Devidas Shirude.
  • Ancillarie Company registered in GTA, Ontario, Canada in March 2016

Insights 2012-2015

  • Ancillarie successfully completed Data Management, Biostatistics and Statistical Programming activities for 830 patients (31878 pages) generic study in Dermatology Therapy. Also supported client in e-submission activities USA FDA and Health Canada.- November 2015
  • Ancillarie successfully completed Data Management, Biostatistics and Statistical Programming activities for 840 patients (27778) pages) generic study in Dermatology Therapy. Also supported client in e-submission activities for USA FDA – September 2015.
  • Ancillarie signed strategic partnership with Latin America & USA Based Companies for Clinical Operation Services.
  • Ancillarie became certified Medrio Partner – May 2015
  • Ancillarie signs strategic partnership with US based Company for Clinical Operation Services
  • Veterans from the industry Dr. Jack Green more than 30 years of experience and Dr. Suresh Bowalekar more than 40 years of experience are on the advisory board of ancillarie to guide the team.
  • Ancillarie support services company was established in 2012. Company provides support services to Pharmaceutical, Biotechnology and Clinical Research Organizations to achieve their goals.

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 :

  • eConsent
  • eRecruitment and pre-screening surveys
  • ePRO and eCOA solution
  • API and philosophy of Interoperability

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.