From preclinical to market access.
Full service in LINK Medical means that we can handle all stages of product development from preclinical to market access. We give you an immediate project value assessment followed by expert rationale and recommendations. Qualified in-house Health Economists, Medical Experts, Pharmaco- and Medical device –vigilance personnel, Statisticians, Data Managers and QA personnel ensure we provide a full service one-stop-shop for our customers.
We take complete vendor responsibility for regulatory guidance and conduct and management of all clinical studies through the whole lifecycle of the product. We can conduct local and global clinical studies though a PM based in one of LINK Medical sites in Norway, Sweden, Denmark and Germany, and through validated vendors when there are sites outside northern Europe.
Our proven Project Management methodology
LINK Medical has a structured approach to project management described in our proven PM methodology LINKplan™. LINKplan™ facilitates consistency in how a project is implemented, managed and reported. Together with the customer we develop the project plan with milestones and decision points, and during this process clarify the scope, expectations risks and risk mitigation measures
For multi-country projects, a lead CRA experienced within the relevant therapeutic area is assigned. The lead CRA provides support to the project manager and project team in all study related activities and is responsible for the clinical operations team of assigned CRAs through all phases of the study. The lead CRA will oversee the processes from site identification and selection, subject enrolment and retention to study closure, and will work closely with the CRA team to drive site performance and to secure timelines, compliance and quality.
Highly experienced and dedicated team are selected
A team of highly dedicated CRAs are selected according to the complexity of the study, the number of sites and the number of subjects at each site. The CRAs will be thoroughly trained in all applicable systems, the study protocol and study related procedures in order to support the sites through all stages and processes of the study. They collaborate closely with the sites to develop and maintain good site relations. Ongoing communication will ensure awareness of timelines, expectations and responsibilities and will maintain high motivation and performance.
Experience in all aspect of Data Management and Statistician
LINK Medical has extensive experience in all aspects of Data Management and Statistics. Our experienced statisticians will provide advice on study design, sample size calculations, randomization and input to the protocol. Our experienced data managers will build the CRF using our 21CFR part 11 compliant eCRF system in close collaboration with Customer.
Certified users and Medical Advisor at your service
LINK Medical has certified users of the EudraVigilance web-based reporting tool (EVWEB) provided by EMA. In clinical trials with pharmaceutical products we use this tool for the expedited electronically reporting of Suspected Unexpected Serious Adverse Reactions (SUSARs) to competent authorities. We also have experience in compiling and submitting Safety Update Reports (DSURs) /annual safety reports to competent authorities and ethics committees.
LINK Medical provides a medical advisor for the medical evaluation of events, i.e evaluation that may relate to the assessment of seriousness, relationship, and expectedness of events and the coding of the events in the MedDRA-system.
International and local regulations and guidelines stipulate that clinical trials should be conducted by people who are qualified and appropriately trained. All LINK Medical team members have a high level of professional experience in their respective function. Study specific training will ensure that all team members are fully aware of all aspects of this specific clinical trial.
We look forward to working with you! At LINK Medical we always make sure that people and plans work together!