Pre-Market Studies

Managing full service medical device clinical investigations

Pre-market clinical investigation is a crucial step conducted before obtaining market approval for an investigational device. It is meticulously designed and executed to validate the safety and performance objectives, as well as the clinical claims identified during the Clinical Evaluation process.

We act as your full service CRO!

At Qmed, we offer full-service support to guide you through the pre-market phase. Here’s how we can assist:
Qmed provide the following services:

  • Clinical Strategy: Assessment of sufficient clinical evidence and risk evaluation and claim analysis, study design, specific regulatory requirements, and sample size determination.
  • Clinical Study startup: Site qualification and selection, Trial Master File build up, site contracting and budget negotiations, logistical support, training and Investigator meeting.
  • Clinical study submissions: Compile submission package to the Ethical Committee (EC) or Institutional Review Boards (IRB), Competence Authorities (CA), local hospital boards and management of amendments and study termination.
  • Clinical document writing: Clinical Investigational Plan (the Protocol, Patient Information and Consent and Investigators Brochure and other technical documents to support the clinical investigation (clinical study management plan such as the Monitor Plan).
  • Monitoring: Site monitoring (on-site, remote, and/or risk-based) and site management.
  • Clinical Data Management: Design the (e-) Case Report Form (CRF), set up of Electronic Data Capturing (EDC), including safety monitoring and management.
  • Biostatistics: Statistical planning and analysis for interim, Data Safety Monitoring Boards and Clinical Study Report.
  • Clinical Auditing: Site, CRO, contractor, sponsor, and pre-inspection.
  • Clinical Project Management: Full clinical study project management (resource management, management of site relationship, progress reporting and risk mitigation), investigator meetings, and interim Clinical Management.
  • Site and sponsor training in ISO14155 and GCP

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Contact information

Koebmagergade 53, 1.
DK-1150 Copenhagen K.
Denmark

+45 56 64 10 10
info@qmed-consulting.com

Our services

Clinical trial management
Regulatory Affairs
Quality Management
Reimbursement & Market Access

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Proud sponsors of
Red Cross and Mothers Aid.

Qmed Consulting is an ISO 9001:2015
& 14155:2020 certified company.