10 Nov 2020

The Trial Start-Up Specialist’s profile

One of the ascending roles, albeit still little known, in clinical research is that of the Clinical Study Start-Up Specialist. What exactly does this professional figure do and what role do they play in a clinical trial?

It’s currently a highly sought-after position, especially in CROs more than in pharmaceutical companies. The Trial Start-Up Specialist assumes a strategic role in clinical research as the authorization process for starting a clinical study is extremely complex; CROs and pharmaceutical companies therefore need trained and highly specialized personnel who are able to coordinate all activities ranging from the submission of a clinical study to the conclusion of the authorization process.

What does the Trial Start-Up Specialist do?

The Trial Start-Up Specialist, usually in possession of a Bachelor degree of Science, is responsible for preparing all the documentation necessary for submitting a clinical study to the Competent Authorities and Ethics Committees of reference, in order to obtain regulatory and ethical administrative authorization.

The role of the Trial Start-Up Specialist is rather transversal, having to manage the following activities including: feasibility study (that is, dealing with feasibility activities), identification and selection of experimental centers, preparation of the documentation to be submitted, quality control of the documentation to be submitted, regulatory ethics submission and related follow-up, contract and budget negotiation.

All the activities within their competence are always carried out in line with the international ethics and quality standards, current regulations, applicable guidelines and SOPs (Standard Operating Procedures).

Therefore, in addition to specialized training, this professional figure must have excellent organizational, communication and problem solving skills as they must relate to the various stakeholders of a study, namely: Sponsors, Competent Authorities, Ethics Committees, Hospital Administration Boards and Clinical Centers. They must also have excellent knowledge of international standards of ethics and quality, current regulations, applicable guidelines, a strong attention to detail and a remarkable aptitude for team work.

OPIS Start-Up Trial Unit is able to guarantee preparation, attention to the customer, management of critical issues, providing a quality service that meets the legal standards and offering its experience and support, both nationally and internationally (EU VHP submissions, management of and EudraCT).

More than twenty years’ experience make OPIS able to provide support for EU VHP submissions and the management of and EudraCT.

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