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Protocol Development

The Heart of the Study

The protocol describes the objective(s), design, methodology, statistical considerations and organisation of a clinical trial, and ensures the safety of the trial subjects and integrity of the data collected. Illingworth Research can develop protocols to suit the global development plans for your products. We firmly believe that it is vital to collect the best quality data and therefore we recommend CRF design be completed in tandem with protocol development.

Our team are able to manage and support you through this process, our diverse experience and friendly can-do approach enables us to gain a true understanding of what your protocol requirements are and hence cater to your individual needs. We are small enough to offer a personal bespoke service but large enough to have the experience and knowledge to support most clinical trial designs.

Experienced Clinical Trial Team

Our experienced clinical team have worked in all trial phases and in a diverse range of therapeutic areas. This enables them to truly appreciate the requirements within the protocol, we also acknowledge the strong relationship between the protocol and CRF which is why we would always advise the two be formulated together. As we say the protocol is the heart of a well run study, however, without a well designed CRF the data may not be collected as required.

During the Development Process Illingworth Research Will:

  • Liaise with Project Managers, Statisticians, Study Physicians, Investigators and KOLs to ensure appropriate study design
  • Conduct literature searches
  • Communicate with statisticians and data management to ensure optimal protocol design
  • Coordinate with data management to ensure compliance with internal systems
  • Ensure that the protocol undergoes internal review as per your company procedures