Study Design & Leadership

Protocol development

Our team and partners bring together years of writing experience and have (co-)authored a multitude of clinical research protocols. Each protocol ensures that the safety of the patients and integrity of the data collected is guaranteed and that the trial design is fully in line with ICH-GCP guidelines.

We ensure that the background, rationale, objectives, design, methodology and organisation of the trial are thoroughly described whilst simultaneously maintaining “investigator and patient friendliness”.

We bridge the chasm between concept and clinical trial design, resulting in a “ready-to-submit” protocol.

Our team and partners have extensive experience with regulatory meetings to discuss a protocol with regulatory agencies such as FDA and EMA. We can also help with the preparation of documentation for submission and we can assist you with the resolution of questions from national health authorities, as well as central or local ethics committees.

Steering Committee

We have ample experience in concentrating the (scientific) leadership of your clinical trial in a Steering Committee. The Steering Committee has an important scientific and clinical advisory function and is involved early on in the development of the clinical trial protocol. We organize the contracting, management and support of the Steering Committee and develop the charters. Our Steering Committee members come from various backgrounds and are always widely recognized as leaders in their field of expertise.

The Steering Committee’s main tasks and responsibilities are to review and co-develop the protocol, to decide on protocol amendments and Safety Board recommendations, and to assist with the analysis and presentation of the results of the study. In addition, the Steering Committee is responsible for making sure that the protocol is strictly being followed in collaboration with the sponsor and CRO.