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More about Clinical studies 

As a European contract research organization (CRO) with offices in Oslo, Stockholm Copenhagen and Berlin we provide our customers and partners with local expertise in the Nordic and European countries.


We work closely in interdisciplinary teams and in a very supportive working environment to ensure the ongoing success of clinical studies, something we have been doing within various therapeutic disciplines since 1995. This provides customers with a great deal of experience to call upon, alongside our enthusiasm and skills, to turn complex challenges into intelligent solutions. Our people are trained in all applicable regulations and guidelines. We create teams with thorough knowledge of the processes and standards of the complete clinical environment.

Project Management

LINK Medical offers a variety of project management services that provide customers with the confidence to undertake projects with us. All projects will benefit from more than 15 years of experience in a wide variety of therapeutic areas. We assist established companies in managing clinical studies and clinical trial programs, we manage the development of regulatory product strategies and we even help start-up companies to manage international CROs.

Our services include:

  • Overall project management, coordinating several or all functions in a project delivered by LINK Medical alone or in collaboration with other parties
  • Functional project management , e.g a CRM, CTL or Sr. CRA integrated in a team that you establish within your organisation
  • Management of other CROs

LINKPlan ™is our work process for project management ensuring a structured and consistent approach to projects. We analyse the individual project to identify the most effective way of implementation. Open communication is a key tool to ensure transparency on project progress and we share project documents and information on a shared web based filing system.

Patient recruitment

We consider patient recruitment and retention a process rather than a single activity. We can work with customers from the outset with protocol development, feasibility studies and site selection. We can manage projects with on-going activities from first patient in (FPS) to last patient out (LPO). We address patient recruitment and retention in a systematic way throughout the planning process and during the trial itself. With our extensive experience, we can bring together all the necessary elements to bring project success. Link Medical has the necessary network and overview of local hospital specialities, expert groups, key opinion leaders, investigators and patient flow, to ensure best-in-class performance. We also offer great flexibility and the ability to perform feasibility studies at a short notice. We analyse the feasibility of performing projects at both a national and international level, as well as at specific sites. We base our recommendations on first-hand experience with the study sites, combined with the criteria defined in collaboration with customers for each and every project.

Monitoring
Our employees have both extensive experience in running clinical studies and solid scientific backgrounds.

All clinical research associates (CRAs) are regularly trained in Good Clinical Practice (ICH/GCP) and applicable regulations and guidelines to ensure quality deliverables.

Monitoring services from LINK Medical are offered either as outsourced to the customer’s office, as home-based or located to our local offices in Oslo, Copenhagen or Stockholm.

Drug Safety
LINK Medical has extensive expertise of pharmacological vigilance activities in the clinical development phase. We have extensive experience in national and international drug safety reporting in clinical trials and post-marketing. This extends from receipt of the initial data to regulatory reporting. We are familiar with commercial databases and have certified users of the Eudra Vigilance web-based reporting tool (EVWEB) provided by EMEA. 

Quality Assurance and Quality Control

We have specialised professionals with broad experience from quality assurance, quality control and quality advisor positions with health authorities and the international pharmaceutical industry. Our expertise can be called upon for review of a single SOP or for setting up a complete quality system. Our services can be used in-house or at the customer’s premises, with subcontractors, or we can take care of specific parts of a company’s processes. Let us advise you on the appropriate quality level of your operation.

Statistics

We ensure that LINK Medical helps to get your numbers and analyses right. We offer broad-based expertise with statistical planning, analysis and reporting of clinical studies in all phases, including submissions to and discussions with health authorities such as the  European Medicines Agency (EMA) and  Food and Drug Administration (FDA).

Data Management

LINK Medical’s dedicated and specialised staff offer a wide range of services for data management in clinical studies. All services from our experienced data management teams are performed according to defined quality standards and are regulatory compliant, including FDA requirements of CDISC data structure for submitted data.

Training

We provide internal training programs in all aspects of clinical studies.

Resources and Expertise

By calling upon our experience from working with a wide variety of customers in all stages of clinical developement, we bring first-hand experience to support and bring on-track projects, wherever they are in the execution process.
We ensure that projects continue as planned when customers and partners lack specific expertise.


  • Need a second opinion or quality control
  • Need a more flexible cost base and flexible resources
  • Experience a workload peak
  • Need support due to job vacancies
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