What is a clinical research organisation (CRO)?

Contract research organisations (also known as contract research organisations or clinical research organisations or CROs) take over or provide support in the planning, implementation and monitoring or data management and reporting or publications of clinical studies.

Who needs a CRO?

Typically, CRO services are used by the pharmaceutical industry in the planning, implementation and monitoring of clinical studies (phase I-IV) of drug trials as well as in the implementation of non-interventional studies (NIS), such as observational studies.

In addition, university or non-university research institutions often need support for their scientific projects with complex protocols or to bridge staff shortages.

Since the entry into force of Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR), the requirements for clinical evaluations have increased and a clinical investigation is required if the information available in the literature is not sufficient (see here for more information). Manufacturers of medical devices should therefore contact a CRO at an early stage for: clinical investigations as part of the authorisation procedure, clinical investigations after placing on the market, other clinical investigations, performance studies, clinical studies, registry studies, systematic data evaluations, observational studies or similar for medical devices, including in vitro diagnostics, digital health applications (DiGA) or digital care applications (DiPA).

What is a CRO and what does it do?

‍Clinical Research Organisations (CROs) are organisations that provide specialised services to the pharmaceutical, biotechnology and medical device industries to support the development and conduct of clinical studies and other research activities. Typical services provided by a CRO to researchers or manufacturers of medical devices, for example, include

• Study conception, planning and design: Support in the development of study protocols and plans.
• Regulatory support: Assistance with the submission of documents to regulatory authorities and compliance with all legal requirements.
• Budget and timelines: Iterative agreements to meet realistic targets and enable meaningful studies.
• Use of electronic data collection systems and a digital study platform: Support from the development of the catalogue of requirements to admission matters
• Data management: recording, managing and analysing study data.
• Monitoring and audits: monitoring study sites and carrying out quality controls.
• Patient management: Support in the recruitment and management of study participants.

These services are critical to ensure that clinical studies are conducted to the highest ethical and scientific standards and that all regulatory requirements are met.

CROs often work closely with academic institutions, hospitals and other companies to translate scientific findings into clinical practice.

There are companies that specialise in individual regions, indications, services or products, as well as large, globally active companies for drug trials. Very few of these companies specialise in medical devices or have experience in this area. The definition of acontract research organisation (CRO) is set out in ISO14155, but is missing from the MDR.

Why the selection of a CRO is a complex process and how it should be carried out

Finding and selecting a suitable contract research organisation (CRO is a complex process that requires careful planning and consideration. Important aspects that play a role in the selection of a service provider for these extensive tasks are

• Experience and skills : related to region, investigational medical devices, study size and procedures, assessment of risks, extent of digitalisation, training and education, ...
• References: Proof of track record in common portals and recommendations from previous customers
• Strong quality management system: certifications and audits, established standard operating procedures (SOP)
• Cost and efficiency: definition of key variables and price-performance balance
• Project management and staff structure: experienced, well-trained and dedicated staff
• Sufficient resources: every clinical study must be the most important in a CRO
• Corporate culture: quality, integrity and technological progress‍

6 steps to successfully selecting a CRO

1. Create a shortlist: Start with a comprehensive research and create a list of potential CROs based on their experience, skills and track record in your specific therapeutic area. Ask around for their reputation and research the relevant databases.
2. Request for Information (RFI): Send an RFI to the selected CROs to obtain detailed information about their services, experience and capacities. Ask for references on previous projects.
3. Request for Proposal (RFP ): Request detailed proposals from the CROs on your short list. This should include a detailed description of the planned study and expected services.
4. Bid discussion meetings: Conduct bid discussion meetings to evaluate the CROs' bids and ensure that they fulfil your requirements. This is also an opportunity to clarify open questions and get to know your future service provider better.
5. Quality assessment: Conduct a thorough quality assessment of the CROs, including audits and verification of compliance with GCP and other regulatory requirements.
6. Contract negotiation: Negotiate contract terms carefully to ensure that all aspects of the collaboration are clearly defined and agreed for the success of your clinical study.

MEDIACC specialises in services in the context of clinical studies, clinical investigations, performance studies or systematic data evaluations of and with medical devices of different risk classes, which in parts go beyond those of classic CROs.

Would you like a technical or regulatory categorisation or support from the initial concept to the complete implementation? Pleasecontact usat !