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Clinical Development

Essential support for your clinical studies

For more than two decades, LINK Medical has been providing clinical development services to the pharmaceutical and medical device industries. Working closely with our clients, we overcome challenges and optimise solutions for the common goal of achieving superior trial outcomes. As part of the strategic partnership we offer, our dedicated teams and modern technology will optimize your clinical trials and accelerate the delivery of your innovative products to the physicians and patients who need them.

We offer end-to-end development solutions for your product or device, starting with early development advice, including regulatory advice meeting planning, development of market access strategies, marketing applications and post marketing activities – all from ONE source.
Our flexible solutions enable us to tailor our services to our clients’ requirements. Whether you need insourcing of people or outsourcing of services, we carefully select the team that will have the most impact on your organization, freeing up your team to focus on what they do best. Our expert staff have significant experience coordinating early phase to phase IV trials, locally and internationally. Our medical team has a variety of expertise across different disease areas, including oncology and haematology, where the conduct of studies presents unique challenges. From planning and feasibility, to the final study report, we ensure the highest quality outcomes and an exceptional customer experience.

Northern Europe Presence and Global Reach

LINK Medical is fully immersed in the markets in which we operate, offering full-service product development for the pharmaceutical and medical device industries, wherever our customers are located. Our integrated presence across Northern Europe enables you to access a rich local network of trial infrastructure as well as crucial knowledge of local regulatory landscapes.

We’ve built a network of trusted CRO partners worldwide to provide added flexibility and global coverage for your specific study requirements. Our partners are selected through our qualification process – evaluating quality, capabilities, delivery, technology and more – to ensure they can provide a seamless extension to our services. Chosen partners are subject to regular re-evaluation to confirm continued to commitment to the values and high standards of LINK Medical.

Overview of services

Clinical Trial Phases
  • First-In-Man
  • Phase I (Including oncology and hematology)
  • Phase II
  • Phase III
  • Phase IV
  • Registries
  • Medical devices
  • Orphan indications
Clinical Trial Management
  • Project management
  • Study team set-up
  • Feasibility and site evaluation
  • Site identification
  • Operational set-up; e.g. plans, guidelines and manuals
  • Vendor selection and management
  • Site contract negotiations and management
  • Investigator and CRA meetings
Risk Based Monitoring and site management

Our Risk Based Monitoring strategy prevents or mitigates important and likely risks to trial data and process and enables us to focus our efforts on the most relevant data and key risk factors of your trial. Our approach includes:

  • On-site and centralized monitoring
  • Focused source data verification in the eCRF
  • Directed monitoring visits to the sites that need most attention
  • Regular review of trial data to identify potential errors early and ensure consistent data
Start-up period
  • Target Product Profile development and training
  • Regulatory Project management
  • Regulatory Services
  • Scientific advice (briefing book, study design, CMC, pre-clinical)
  • Regulatory product strategy development
  • Core Document development (protocol, IB, IMPD etc.)
  • Clinical Trial Applications, including to biobanks
  • EU Legal Representation (for non-EU based clients)
  • EU GDPR Representation (for non-EU based clients)
Maintenance period
  • Site initiation and close out
  • Study subject recruitment planning, follow-up and reporting, contingency planning and actions
  • eTMF/TMF Management and quality control processes
  • Read World Evidence
  • Safety management and reporting
  • Medical monitoring through inhouse medical experts
  • Data Safety Monitoring Board formation
  • Training
  • Data management
  • Statistical involvement
  • Quality assurance/quality control
Closure and reporting period
  • Final data cleaning and database lock
  • Data sets
  • Statistical programming and analysis
  • Study report and submissions

Head of Department

Marie Moores
Executive Vice President International Operations

Marie joins LINK Medical with a background in senior management and board membership within the CRO industry for over two decades. She holds a degree in Clinical Research and has longstanding experience in clinical development and regulatory strategy within the field of oncology, advanced therapies, biologics and gene therapies. She also serves the European Commission in reviewing the progress of Horizon 2020-funded clinical trials as an external expert and monitor.

marie.moores@linkmedical.eu