Project Introduction

This document is a Request for Proposals (RFP) regarding vendor capabilities for technology and test development support services for a professional certification program.  CDISC is seeking to develop and offer Professional Certification for individuals with a significant level of expertise implementing CDISC standards.

Background

CDISC (officially “Clinical Data Interchange Standards Consortium” and pronounced SEE-disk) is a standards development organization (SDO) headquartered in Austin, TX.  Founded in 1997, CDISC has developed a harmonized suite of data standards to provide lifecycle support for clinical trials data. CDISC’s suite of standards includes Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM), which are required for all clinical trials data submitted to the United States Food and Drug Administration (FDA) and to the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan. CDISC standards are recommended for data standardization by National Medical Products Administration (NMPA) in China, Innovative Medicines Initiative of the European Union, and National Cancer Institute of the US National Institutes of Health among other entities.

CDISC Standards in the Clinical Research Process.png

Scope of CDISC Standards: CDISC anticipates individual certifications in SEND, CDASH, SDTM, and ADaM.

From the beginning, the CDISC standards have been developed by volunteers.  Volunteers are professionals from a broad range of organizations, including pharmaceutical, biotechnology and medical device companies, contract research organizations (CROs) and other service providers, academic research organizations and software vendors. 

Because CDISC standards are required for submission of clinical data as part of the regulatory approval process in the US and Japan, there is a large demand for professionals who have significant experience standardizing datasets as well as integrating CDISC Standards into an organization’s data management systems and processes.  A recent CDISC customer survey indicated very strong support for a certification program, both from organizations who need to hire CDISC Standards experts and from professionals who would like to distinguish themselves to potential employers.

Vendor Selection Process and Timeline

RFP Certification Timeline.png

  • Issue RFP 19 April 2019
  • Responses ~5 weeks later 24 May 2019
  • Vendor selection 7 June 2019
  • Launch 16 October 2019

Objectives

CDISC aspires to provide professional certification for all four Foundational Standards and plans to begin by offering SDTM Professional Certification in the US in October 2019. Within the first year following initial launch, we expect to roll out the program in Europe and in Asia, as well as expand it to our other standards.

CDISC expects certification to be valid for two years and may be renewed once without having to take a new exam. For the first renewal, certificants will demonstrate having successfully completed six hours of relevant training in an IACET-certified training during the first two years of certification.  After four years of certification, including one renewal, or after any break in certification, the certificant will be required to re-qualify and to successfully re-take the exam.

To qualify for the certification, a potential certificant will need to demonstrate at least three years of relevant work in the field. CDISC will administer the qualification portion of the certification process.

Qualified potential certificants will be required to complete a written exam. The exam will be composed of a series of 20 questions drawn at random for each test taker from a potential universe of 200+ questions.  It is expected that there will be three bands of questions: 5-7 randomly selected questions in each band to form the 20-question test. The questions will be written by CDISC staff and volunteers (some of whom may be compensated for their time or for their questions).

CDISC expects that successful completion of the exam will require correctly answering at least 18 of the 20 questions. Potential certificants should know their test results instantaneously. It is desirable, but not required, that potential certificants are showed any wrong answers and a corrected answer prior to leaving the proctored exam space.

CDISC expects that at most 85% of potential certificants will pass the exam. The certification exam must be rigorous to ensure that individuals who pass are well qualified to meet the needs of the CDISC community. CDISC expects that potential certificants will pay once to apply for certification and an additional fee up to two times in the following six months to re-take the exam should they not be successful in passing the exam initially.

CDISC staff will manage a database of potential certificants; successful certificants; and the date of their certification.  CDISC staff will provide successful certificants certificates.

Certification Support Services Overview (Requirements)

CDISC seeks the following services to support the development, launch and operation of our certification program:

  1. Overall certification program design: best practice advice and benchmarking support regarding requirements for initial certification and renewal.
  2. Exam development support.
    • Teach one webinar twice (i.e., the same content, in two distinct sessions) to CDISC staff and volunteers on the essentials and parameters of developing effective certification test questions. One webinar will be held in the morning US ET to accommodate European participants. One webinar will be held in the evening US ET to accommodate Asian participants. North American participants will select the webinar to attend at their discretion.
    • Coordinate with CDISC staff developing the 200+ question database.
    • Develop a technical platform to support development and administration of exam, including random generation of questions for potential certificants.
  3. Test proctoring services. The ability to provide the option for test administration in locally operated test centers, or proctored support for administration at a publicly accessible venue. Testing available in US, Japan, the European Union required. Testing available globally preferred.  All potential certificants must appear in person and show photo ID. The exam will be time-limited.
  4. Translation of exam questions into Japanese.
  5. Translation of exam questions into Simplified Chinese.
  6. Monitoring and analysis of test results to measure test effectiveness and identify areas for improvement.

A potential vendor may bid on one or more lettered items above. CDISC reserves the right to select one or more vendors, and may ask a vendor that has bid on more than one lettered item to negotiate a contract on only one lettered item from the list.

Instructions to Potential Vendors

Point of Contact for Questions

Sally Cassells, Sr. Director, Data Exchange Standards and Certification

Email: scassells@cdisc.org or Telephone:  +1 512 363 5826

Submission of Responses 

Please address your formal proposal by 24 May 2019 by email to Marine Laurent, Chief Operations Officer - jobs@cdisc.org

Response Format/Information Requested

  1. Please indicate, which of the lettered items above, your firm is bidding on and the price for each item.
  2. Contact info for primary contact including mailing address, email address, and cell phone number.
  3. General business background: year, state and/or country of incorporation, annual report.
  4. High-level description of your client base – number of customers, industries represented, experience working with the pharmaceutical and/or health care organizations, data management professionals, in regulated industries, standards development organizations. Please identify potential conflicts of interest.
  5. Provide a description of your technology platform for test administration and monitoring.
  6. Experience with certification of standards organizations, life sciences/health care/clinical research IT, volunteer organizations.
  7. Experience with Certification Exam development with volunteer organizations.
  8. Solution you propose for delivering the exam in the countries proposed and for monitoring and maintaining the exam when the content is evolving rapidly.
  9. Geographical presence – specifically in China, S Korea, Japan, US, Canada, UK, European Europe, Europe outside the EU, S. Africa, Australia, New Zealand.
  10. At least two client references: one current with similar services, former or current within similar industry.
  11. Please note if you will provide a better total price if all letters items are awarded to you and indicate that total all-in price.
  12. If there are any assumptions CDISC has made in this RFP that you feel are unwarranted or ineffective to the goals of the certification program, please note what you would recommend instead.