Applied Clinical Services

Our Services

Applied Clinical Services (ACS) provides flexible, personalized, and cost-effective services to medical device companies in meeting the ever increasing clinical evidence needs, to help companies grow and develop their business in the European markets.

Product Clinical Evidence Strategies

Clinical Evidence Strategy development tailored to your business needs includes the following key elements:

  • identification of clinical evidence needs in discussion with in- and external stakeholders,
  • definition of a clinical program including concept proposals to ensure the best possible trial design in line with the EU and US regulatory strategy,
  • development of clinical trial timelines and budget, and
  • a focused evidence based publication and sales training strategy.
Clinical Trial Management

ACS’ support to design, plan and execute a successful clinical study program from start to finish, include the following services:

  • clinical trial design, protocol, and eCRF development in line with the applicable standards such as ISO 14155,
  • regulatory submissions & follow-up as applicable,
  • clinical project management, including CRO oversight and auditing,
  • training of study teams on ISO 14155, Device Related Event reporting (MEDDEV 2.7.3, 2.12.1 and MDR), and the Study Protocol in line with your needs, and
  • control of clinical trial timelines and budget.

Medical writing/Clinical Evidence presentation

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ACS provides support to help you develop clinical project documents in line with the applicable regulations and directives, including but not limited to:

  • clinical evaluations in line with MEDDEV 2.7/1 and the MDR,
  • post-market surveillance and post-market clinical follow-up plans and reports per MEDDEV 2.7/1, 2.12-1, and the MDR)
  • Investigator’s Brochure with all non-clinical and clinical information on product safety and performance
  • clinical trial protocol and report in line with the clinical strategy and ISO 14155, and
  • generation of marketing & sales clinical materials and training
Site monitoring & auditing

ACS helps you to ensure the ethical, scientific, and regulatory integrity of your clinical data through strong and constructive relationships with investigative sites, and with experienced team members in Austria, Denmark, France, Germany, Spain, and The Netherlands, can help you by performing the following activities on your behalf remote or on-site:

  • Site initiation visits & reporting,
  • Interim monitoring visits & reporting
  • Site close out visits & reporting
  • Site audits & reporting per audit plan

Our locations in Europe