Archer-Research-Medical-Device-CRO-Biovi

OUR

SERVICES

We match our services, expertise, budget & timelines to your specific clinical needs.

Archer-Research-medical-device-cro-manag

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FULL SERVICE CRO

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SPECIALIZED IN
MEDICAL DEVICES

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WITH A
PERSONAL APPROACH

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We help you evaluate and fill your gaps in pre- and post-market clinical evidence and provide A to Z support for clinical investigations and registrations in Europe. Each study design has its strengths and limitations. Together we define the appropriate design to maximize quality, minimize risks and guarantee a patient-centered approach. We have extensive experience in setting up the below study types:

 

  • observational (registries), interventional and epidemiologic;

  • monocentric & multicentric;

  • prospective & retrospective and

  • investigator-initiated.

During the study conduct phase, our risk-based approach allows us to trigger relevant actions. This enables an efficient and qualitative execution of your project.
 

ELECTRONIC DATA CAPTURE

Your custom-made electronic Case Report Form, designed and managed in-house.
 

We improve the efficiency and quality of both data entry and data monitoring. Your data collected in our EDC will be complete and accurate, ready for biostatistical analysis.

  • including an online tool for subject randomization

  • developed and validated in-house, ensuring time and
    cost efficiency and no third-party helpdesk

  • real-time remote access, enabling faster decision making
    and supporting adaptive study designs

  • eliminates transcription errors prior to being accepted
    in the database

  • facilitates the process of clarifying data discrepancies
    by automatically identifying and resolving data issues,
    which reduces the number of on-site visits required.

 

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Our expertise is strongly focused on the medical device industry, enabling us to excel in cost-efficiency. We deliver valuable clinical data for devices to meet the medical needs for the patient and to continuously monitor the quality and safety of the device during the device lifecycle.

At Archer Research, we offer a broad experience in study planning and coordination in line with ISO 14155, ISO 9001, Medical Device Regulation (MDR) 2017/745, Good Clinical Practice (ICH/GCP), the Declaration of Helsinki and the applicable national regulations.

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At Archer Research, we value a personal approach.

No changing point of contact, no endless handovers, no unnecessary complex decision-making procedures.

 

From start to finish, one of our dedicated research professionals will be your main point of contact.

This allows us to build trust relationships not only with our sponsors, but also with the site staff conducting the studies and third parties. This way, we can guarantee a smooth and a continuous follow-up and progress of your project.

 

Our personal approach further leads to close collaborations with key opinion leaders and renowned investigators, as well as with scientific societies and universities. This brings experience on an extensive range of projects in various therapeutic domains.