Cooperation among a diverse group of stakeholders—including research sponsors (industry, academia, government, nonprofit organizations, and patient advocates), clinical investigators, patients, payers, physicians, and regulators—is necessary in conducting a clinical trial today. Each stakeholder offers a different set of tools to support the essential components of a clinical trial. Time, money, personnel, materials (e.g., medical supplies), support systems (informatics as well as manpower), and a clear plan for completing the necessary steps in a trial are all part of the clinical research infrastructure.  

Some of the challenges to participating in clinical research 


the time and financial demands of clinical practice;

  •  
  • the overall shortage of cardiovascular specialists;

  • the increasing complexity of regulations;

  • the increasing complexity of contracts;

  • the lack of local supportive infrastructure;

  • inadequate research training;

  • less enjoyment from participation (e.g., increasing business aspects, contract research organization pressures); and

  • data collection challenges (medical records, reimbursement, quality control, pay for performance).

 

​Our clinical trial consulting services include 

Regulatory support 

 

Clinical trials management 

Quality compliance and audits 

  • Good Clinical Practice (GCP)

  • Good Laboratory Practice (GLP)

  • Good Pharmacovigilance Practices (GVP)

  • Good Quality Practice (GQP),

  • Good Manufacturing Practice (GMP)

Adverse events and post market surveillance 

Clinical Trials for Medical Products in Europe

Our experts can help you manage and expedite your clinical trials in Europe to get your products to market sooner.

When registering new medical products in Europe, there are various reasons companies may want or need to conduct local clinical trials. The most common reason is that the local government may require the clinical data for product registration. In addition, the large, genetically diverse population in Europe creates ideal sample populations, and the cost to perform clinical studies in Europe may be lower than in other countries. In some cases, post market data may be required.

An understanding of the regulatory requirements in each European country and experience in dealing with the local regulatory authorities is essential in administering a smooth, successful clinical trial in Europe. F7 Global can act as your contract research organization (CRO) or help you identify a qualified European CRO. Our on-the-ground teams in Europe are highly experienced with the related regulatory affairs and can locally manage the full clinical trial process to ensure that it is conducted effectively and successfully.

Lab Experiment

We offer the following services for medical device, pharmaceutical, and biotechnology companies looking to conduct clinical trials in Europe:

  • Clinical Trial Consulting Services
    F7 Global will provide clinical trial consulting services, including consultations with all local European governments. We can help you develop an effective Clinical Investigation Plan with clinical trial strategy, clinical trial study design, and clinical trial protocol.

  • Regulatory Support
    We can assist with clinical trial applications (CTA) and clinical trial notifications (CTN) as required for clinical trial initiation in each European country. Our on-the-ground teams consist of experienced professionals who will meet with the appropriate European regulatory agencies on your behalf throughout the clinical study. We will provide guidance on meeting the Institutional Review Board (IRB) and Independent Ethics Committee (IEC) requirements.

  • Clinical Trials Management
    We can comprehensively manage the clinical trials process by conducting the trials and completing the clinical trial reports. Our experts will evaluate clinical trial and non-clinical trial data; conduct gap analyses; and determine safety and efficacy, along with primary and secondary endpoints, as required for your specific product.

  • Quality Compliance and Audits
    We can conduct on-site audits of your clinical trials and consult on the guidelines for Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Pharmacovigilance Practices (GVP), Good Quality Practice (GQP), Good Manufacturing Practice (GMP), etc.

  • Adverse Events and Post Market Surveillance
    We will report adverse events and implement suggestions on additional tests and required data. We can assist in post-approval and post-clearance clinical trials to maintain the safety, efficacy, and performance of the product through its life cycle.

Clinical trials that are conducted properly will facilitate a smooth registration approval process and expedite access to the European markets. If you need assistance with clinical trials for your medical product in Europe, contact us now for a consultation with our European regulatory experts, or select your target market for more information regarding clinical trials in each European country.