Ensuring and making use of compliance in clinical trials

Approval of relevant study documents by competent authorities and ethic committees is the key requirement for setting up a clinical trial. A concordant positive vote from all regulatory institutions is a necessity for commencing any clinical research study involving human subjects.

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We closely collaborate with federal, state and local regulatory agencies to obtain an approval of study documents within an expected time frame. We provide regulatory supervision during study conduct which is essential to implement amendments and additions to the study protocol while meeting the most current regulatory requirements.

 

Our flexible and responsive Regulatory Affairs team ensures that the projects for which the responsibility is transferred always comply with the regulations and laws pertaining to clinical research. We support our customers in all central and local application activities, including the identification of suitable trial sites, the preparation of trial-specific essential documents, the submission of study protocols and related documents, regulatory maintenance during the study conduct and end of trial notification.

Our Regulatory Affairs services include

Assurance of regulatory prerequisites of trial sites

Development

Identification of trial sites

Development

Implementation of country-specific requirements (e.g. biobank agreement and compliance with general data protection regulation)

Development

Setup

Feasibility assessments of trial sites

Development

Setup

Preparation of submission packages and CTAs

Development

Setup

Submission of study documents to Ethics Committees and competent authorities including follow-up until project approval

Setup

TMF setup and maintenance

Setup

Submission of amendments

Setup

Execution

Reporting procedures during the study as per local regulations (e.g. start/end of study, annual progress report)

Execution

Closure

Interaction with local regulatory authorities

Development

Setup

Execution

Closure

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