Clinical Trial Planning and Design

Nikolai Nikitin 2

We recognise the importance of having a robust, practical and, importantly, workable protocol that conforms to Good Clinical Practice and all appropriate regulations: one that is well-designed and fit for its specific purpose, one that does not require endless future amendments to get round inappropriate recruitment-limiting enrolment criteria and collection of unnecessary data – the appropriate outcome measures and end-points, the right number of patients, and optimum duration of follow-up are determined at an early stage in the planning process.

Depending upon your requirements, our friendly collaborative approach can couple your experts with ours to produce the most intelligent solutions.  We know, intimately, the different rules, regulations and requirements in the countries we operate – the vagaries of which can cause delays if pro-active planning is not sufficient to accommodate them.

If we are involved before the protocol is finalised we can help to ensure its optimum design and practicability.  We are, of course, happy to be presented with a finalised protocol around which the study can be planned and we can often offer suggestions, if appropriate, for amendments to optimise recruitment at our sites without compromising the robustness, safety or validity of the study before obtaining the necessary approval and permissions (a relatively simple process in the territories in which we operate!).

Like the Competent Authorities, we understand the importance of Risk Assessment in planning clinical trials and research: the process of identifying any potential hazards associated with the trial, and assessing the likelihood of those hazards occurring and resulting in harm. This includes risks to participant safety in relation to the IMP or device as well as other potential risks related to the design and methods of the trial, which can subsequently be minimised.

All our sites, conducting trials to the highest standards of GCP, have a large patient recruiting capacity and a proven track record of efficient timely recruitment of qualified patients.  Selection of the appropriate sites to approach for the study is an important part of the planning process.

We always plan to succeed!