Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.
We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model – leveraging full-service, functional service provider and consulting – allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.
For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.
The purpose of the mission is to contribute to the implementation and monitoring of clinical trials in collaboration with the project manager statistician and the clinical team, so that the statistical analyses meet the primary and secondary objectives of the study while respecting the deadlines, quality, regulatory requirements, and guidelines of the pharmaceutical laboratory.
– Participate in study design, establish sample size, and even develop simulation programs to evaluate the operational characteristics of a trial.
– Write the study synopsis and protocol
– Review and contribute to the drafting of study documents: Case Report From (CRF), Central monitoring Plan (CMP), Study Risk Management Plan, IRT specifications….
– Determine the randomisation scheme and ensure that it is carried out correctly by the IRT.
– Define the specifications of the subcontracting to the CRO in charge of the study and the technical specifications given to this CRO.
– Write a precise, clear, and complete statistical analysis plan (SAP) with the most appropriate methodology and data presentation. Construct the list of statistical appendices for the study.
In the case of a study subcontracted to a CRO, proofread, and validate the statistical analysis plan (SAP)
– Supervise the subcontracted biostatistical and programming activity (including data monitoring, preparation of ADS and report tables)
– Verify CRO deliverables
– Validate SDTM/ADAM documentation (mainly derived variables).
– Communicate, discuss, and interpret statistical results, including joint development of the clinical study report.
– Participate in submission activities.