Clinical Affairs

Qmed - your full service medical device CRO

Collaboration, Alignment, and Adherence

Conducting clinical studies represents a substantial investment in bringing emerging devices to market. Our strength lies in crafting a meticulous Clinical Evaluation Plan, executing it to meet pivotal commercial milestones, and delivering insightful analyses crucial for successful commercialization. The absence of cooperation, coordination, and compliance in this process often leads to unwarranted resource wastage. We understand that establishing trust takes time, but we begin with open and candid discussions about your clinical affairs service requirements.

How We Can Facilitate

In an era of ever-changing global regulations, innovative study designs are in high demand. Our multilingual team is well-versed in ICH-GCP, FDA CFR, ISO 14155 standards and other national regulations, capable of supporting the entire regulatory approval and monitoring lifecycle. With a collective experience spanning over a century, we stand among the most accomplished teams in the field of medical device clinical research. Bolstered by our accredited Quality Management System (QMS), we ensure high quality standards are maintained, irrespective of your study’s scale or geographical location.

As a distinguished medical device Contract Research Organization (CRO), Qmed Consulting extends a comprehensive array of strategic consulting services tailored to various medical device and In Vitro Diagnostic (IVD) clinical studies.

Our portfolio encompasses a spectrum of studies for all classes of products (medical device class I to III), including:

  • First in Man
  • Pre-Approval Clinical Investigations
  • Post-Market Clinical Follow-Up (PMCF) studies
  • Performance Evaluations (IVD)
  • Registry Studies

Clinical affairs

CRO services have been fundamental for Qmed Consulting since 206, with over 500 completed studies within all device risk classes.

Set-up

  • Regulatory submission to ethical committee and competent authorities
  • Contract management
  • Implementation of the previously developed risk-based plans
  • Statistical programming
  • Database design and validation
  • Trial Master File and Site File creation
  • Training of study teams
  • Assembling safety boards
  • Performance of site assessment and site selection
  • Performance of site initiation visits
  • Import and export management

Live Phase

  • Ongoing project management
  • Remote and field monitoring
  • Site communication and management
  • Handling of non-compliances
  • Data management
  • Query management
  • Safety management
  • Vendor management
  • Site payment
  • Manage all DSMB/CEC activities

Close Down

  • Data lock and analysis
  • Final audits (Site and Trial Master File)
  • Final safety reviews
  • Support through inspections
  • Final reports to the authorities

Pre-Market Research

Bringing Your Medical Device to Market

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!

  • Study planning
  • Clinical document writing
  • Site management
  • Data and safety management
  • Auditing
  • DSMB/CEC set up and management

Post-Market Research

Maintaining Your Medical Device in the Market

For post-market clinical investigations, adherence to the principles outlined in the ISO14155:2020 and other regulations and guidelines is recommended, as far as they are relevant, taking into account the nature of the clinical investigation. According to this standard, post-market clinical investigations are conducted subsequent to the market approval of a medical device. Their purpose is to address specific inquiries concerning the clinical performance, effectiveness, or safety of a medical device when used in accordance with its approved labelling. In comparison to pre-market studies, post-market investigations may benefit from certain exemptions outlined in the standard, making these studies administratively simpler.

How Qmed Can Assist You

  • Set up a Post Market Clinical Follow-up (PMCF) plan including the use of registers and surveys
  • Write up the applicable clinical documents needed
  • Assure the needed approvals if applicable
  • Manage the PMCF activity
  • Collect and analyse data
  • Reporting and presentation to Notified Bodies
Please note that if marketed products are being investigated for new indications, beyond those described in the approved labelling, normative guidelines for pre-market clinical investigations apply.

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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

Working with us

General Terms and Conditions
Erasure policy
Data protection and privacy policy

Our expertise

Global Collaboration
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Therapeutic Areas

Proud sponsors of
Red Cross and Mothers Aid.

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