Protocol Writing & CRF Design

The manner in which a protocol is put together is equally important to the data produced
and how it is presented, as it dictates the way a study will be conducted.

Richmond Pharmacology’s Medical Writing Department has considerable experience in producing Clinical Study Protocols and Study Reports according to ICH guidelines. Each protocol is developed in collaboration with the Sponsor in order to fulfil Sponsor requirements and objectives. All protocols are written by Richmond Pharmacology’s medical writing team, with input from Richmond Pharmacology’s medical team including the Medical Director.

Our dedicated CRF design team use Indesign to create Case Report Forms, Source documentation, Diaries and Urinalysis booklets. Each CRF is based on our RPL standard library of CRF modules (in accordance with CDISC). However Richmond Pharmacology will modify or create CRFs in accordance with your needs to ensure you receive the module you specifically require.

CRF instructions are prepared alongside the design of the CRF to ensure site staff are very clear on how to complete the required pages. These can be incorporated into the document itself or can be a standalone document.