Clinical Investigation

Our services along the whole product lifecycle

Services by stage

Development Regulatory Affairs Market Access Vigilance Quality & Compliance Digital Health Case Studies

Development Strategy Clinical Investigation

Due Diligence Gap Analysis Technical file & CE Mark EUDAMED Advertising & promotion Local Representation Person Responsible for Regulatory Compliance (PRRC)

SETTING UP THE CLINICAL EVIDENCE

RPN is more than just a service provider: we are strategic partners in every step of a MedTech’s clinical journey.

In the clinical investigation phase, our services include:

Advice on Trial Design.
Selection and coordination of clinical CROs and CMOs.
Advice on European Clinical Investigation requirements and support for submissions.
Regulatory and scientific support for the writing of the CTA-related documentation (including Protocol, ICF, IB report).
Local Regulatory Authorities and Ethics Committee liaison.

Medtech