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Clinical Development

Essential CRO 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

By implementing a Risk Based Monitoring strategy we can work smarter and more effectively without compromising the quality of the clinical trial. By doing so we can focus our efforts on the relevant aspects of the trial and avoid any potential pitfalls. Our approach includes:

  • On-site and centralized monitoring
  • Targeted source data review and verification
  • Directed and flexible monitoring visits to sites, depending on need
  • Continuous review of trial data to identify potential errors and ensure high quality 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

Johanna Sundberg
VP Clinical Operations
Johanna holds a PhD in toxicology and has over 20 years’ experience within research and the CRO industry, working extensively within phase I-II studies and associated project management. Johanna has been part of the Uppsala team since in September 2015 with different management roles including Director of Project management. Prior to that, she transferred from Quintiles where she held the position of Director, Clinical Project Management. Today Johanna is the VP of Clinical Operations where she supports Nordic teams as an international leader.

Johanna.Sundberg@linkmedical.eu