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
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.
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.
management, coordinating several or all functions in a project delivered
by LINK Medical alone or in collaboration with other parties
project management , e.g a CRM, CTL or Sr. CRA integrated in a team that you
establish within your organisation
- Management of other CROs
™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.
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
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.
Our employees have both
extensive experience in running clinical studies and solid scientific
All clinical research
associates (CRAs) are regularly trained in Good Clinical Practice (ICH/GCP) and
applicable regulations and guidelines to ensure quality deliverables.
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.
LINK Medical has extensive
expertise of pharmacological vigilance activities in the clinical development
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
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.
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).
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.
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.
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