CRO – Contract Research Organization

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Post-Marketing

Adding value after market authorization


A strategic partnership with LINK Medical will empower your business with the expertise needed to confidently maintain your marketed product. With a profound knowledge of local and international regulatory landscapes, experience in Real World Evidence, and dedication to product safety, we are well positioned to help you overcome every post-marketing challenge.

When it comes to post marketing studies, we have the EDC technology to shorten the study set-up time and to provide the evidence that you need for continued marketing authorization. Our in-house staff of late-phase experts are always deeply involved in your studies to provide strategic and operational leadership, adding value to your business.

Regulatory

With one of the largest teams of experienced regulatory professionals in the Nordics, we can help you confidently navigate every post-marketing regulatory challenge.  We provide a complete range of services for successful preparation, submission, and support of pharmaceutical, biopharmaceutical, and medical device dossiers. Our strategic partnership will facilitate your contact with Competent Authorities and Notified Bodies during the maintenance phase of your products, and enable development of impactful post-approval strategies. Read more

Pharmacovigilance

We are dedicated to ensuring good pharmacovigilance (PV) practices, and our team of PV specialists will support you with planning of all post-marketing pharmacovigilance activities. Medical expertise is at the heart of what we do, and our team of medical doctors can ensure efficient medical monitoring of your products on the market, including handling medical queries and suspected adverse drug reactions. Read more

Market Access & Real World Evidence

Our excellent RWE team supports projects with valuable data needed to make evidence-based decisions. Our RWE studies generate relevant evidence through the design and execution of prospective and retrospective observational studies, including registries, safety studies, and expanded access programs. We also have strong capabilities within conducting health economic analyses and cost-effectiveness analyses. Read more

Quality Assurance

Our quality assurance expertise can be a valuable and essential asset for your post-market needs. Maintaining a robust quality system is a challenge for pharmaceutical, biotech, and medical device manufacturers, but our qualified QA experts can ensure that you stay compliant with regulations and industry standards. Every company has unique needs, and our extensive experience with developing quality management systems means we can confidently tailor the framework of your specific quality program, including the necessary policies and standard operating procedures (SOPs). With a Head of Department that was previously the Head of Inspection at the Norwegian Medicines Agency, you can rely on our rigorous dedication to quality.

Our in-house QA personnel has vast experience in the field including some as former GCP inspectors. They are a cornerstone for guiding clients do the right things not only things right.

Clinical operations

Collecting accurate, high-quality data is a critical factor for driving superior clinical outcomes. However, the system in place must be as user-friendly as possible for site staff to save time and prevent mistakes. Our embracement of modern technology and emphasis on designing phase IV trials with market needs in mind is what sets us apart from other CROs. With many functions directly built into the eCRF system, transformative Viedoc™ technology can avoid poor quality data and many of the other common quality issues and pitfalls in phase IV trials. Read more

Biometrics

Our high rate of returning customers is partly due to the emphasis we place on reducing study start-up times. We deliver this through our flexible, experienced Biometrics specialists and expertise as Viedoc master users. Viedoc is a radically efficient and intuitive EDC technology, and our EDC team will analyze study protocols and identify the optimal setup solution in weeks while reusing any aspects of the eCRF set-up from our vast library of previous trials. With our capabilities, we can achieve a normal set-up timeframe of Viedoc (eCRF) in only 6-8 weeks depending on trial complexity and resourcing. Once set up, the system is built with a variety of intuitive and cost-effective solutions that facilitate your phase IV trials.

The team can provide you with customized reports, programmed in SAS, and data sets that are compliant with regulatory standards. Read more

Strategic Advice

The development of a product does not end with marketing approval or even reimbursement. Life cycle management involves evaluating numerous, often competing, opportunities and challenges, all of which will have a scientific core. Scientifically grounded external advice can help you with Life cycle management decisions. For new customers, we offer a free one to two-hour meeting with our Strategic Advice group which is led by our Medical Director and experienced people in Clinical Development, Medical Writing, Quality, Regulatory, Statistics, and Business Development. The free consultation is for a general Scientific advice session to chisel out initial areas to clarify, and help in formulating the questions that will help take your product further. Contact us to schedule your initial meeting free of charge here.

Business Area Head

Marianne Holst
Executive Vice President Regulatory and Safety Operations
Marianne is a Registered Nurse from Copenhagen and has more than 30 years of experience within clinical research, joining LINK Medical in 2011. For more than 10 years she worked in the pharmaceutical industry as CRA, Project Manager and Line Manager within various indications. For the last 19 years, she has worked in CROs where she held the positions of Head of Clinical Research and General Manager respectively.

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