Common Language Evaluation and Reconciliation (CLEAR)

CLEAR

Data shows that it takes up to 13 weeks to execute a contract globally, and over 10 weeks in North America. The Common Language Evaluation and Reconciliation (CLEAR) language was created in collaboration with several sponsor and CRO partners to address the obvious need to speed up the contract negotiation and execution process.

The purpose of CLEAR is to streamline contract negotiations and thereby accelerate site initiations, leading to increased recruitment timeliness and reduced study start-up costs. Improving productivity by reducing cycle times and accelerating clinical research will allow the industry to get new treatments to patients faster, without sacrificing quality. This initiative benefits all  clinical research stakeholders —sponsors, CROs and sites—but most importantly, patients.

Objectives:
  • To enable sites and provide them the tools to aid in the rapid execution of clinical trial contracts
  • To provide agreeable language to pharmaceutical and CRO partners to speed contract execution
  • All with the intention of bringing trials and medicines to patients faster

Below you will find two documents, created with the intent of accelerating the contract negotiation and execution process:

CLEAR_SSS_10-14-16_Final

CLEAR White Paper
The CLEAR white paper outlines 5 commonly contentious contract clauses that have been mutually agreed upon by the CLEAR Working Group participating companies: Indemnification, Intellectual Property, Publication, Subject Injury, Confidentiality. We encourage sites to use this language in their contracting negotiation process to increase the possibility of timely contract execution.

CLEAR Justification Language_Final_V2-1

CLEAR Justification Supplement
The CLEAR Justification Supplement is intended for sites to use alongside the CLEAR contract language white paper as additional guidance supporting the requested contract amendment.

Deena-Bernstein

Deena Bernstein

Project Chair

Dex Bilkic, MBA

Bayer
Project Chair

Jimmy Bechtel

SCRS
Project Lead

Russell Kemmerle

SCRS
Project Lead

The following partners have committed to accept the CLEAR language

AstraZeneca
lilly
pfizer_small
Sanofi-e1476278477393
syneos-200px

Acceptance of the CLEAR language is not limited to these companies.