What is a Contract Research Organisation (CRO) and why do you need one

Working with a Contract Research Organisation (CRO) can make the difference between your IVD development successfully progressing to market or missing it entirely.

So, what is a Contract Research Organisation (CRO)?

A CRO is a Contract Research Organisation that provides clinical study (clinical investigation for medical devices and clinical performance study for IVD medical devices) outsourcing management services to the pharmaceutical, biotech, and medical device organisations.

What are the key responsibilities of a CRO within a clinical/device investigation?

Contract Research Organisations are key players in clinical research, since they have the knowledge, experience and resources needed to provide end to end support and expertise throughout the clinical study process. A clinical CRO will take on a number of key responsibilities including.

• Study design and planning: Assisting the client in the drafting of a test site/clinical performance study protocol, patient recruitment and patient engagement/outcome strategy.
• Regulatory compliance: Drafting and submission of all regulatory submissions e.g. CPSP and investigator brochure, ensuring compliance to all relevant local and global regulations.
• Project management: timeline, resource and budget management and reporting.
• Site selection and management: Responsible for identification of suitable sites; patient population/samples, infrastructure and experience considered. Responsible for site qualification, contracting, set up, training and regular monitoring throughout the conduct of the study. Also responsible for the collection and filing of essential documentation generated throughout full duration of the study.
• Data Management and statistical analysis: Responsible for creation of a data management plan, implementation, maintenance and monitoring of Electronic Data Capture (EDC) system. A CRO will also develop and perform interim and final statistical analysis and interpretation of all study results against primary and secondary study outcomes
• Safety reporting and compliance: Ensuring that all aspects of the study are GCP compliant and align with clinical/device protocols. Monitoring and reporting of serious/adverse events to relevant regulatory bodies and ethics committees.
• Training: ongoing training of site staff in the study protocol to ensure they are well-prepared to conduct the study and have sufficient training on EDC and reporting systems.

What to consider when selecting a Contract Research Organisation

• Experience: A great CRO will have expertise in a specific therapeutic or study area, demonstrating a proven track record delivering similar programmes, demonstrated by a strong portfolio of successful case studies and client references
• Global Footprint: Many large pharmaceutical or device studies will require clinical site and testing laboratories throughout the world, making an understanding of local regulatory environments, patient populations and clinical practice essential
• Operational Excellence: Efficient and clear project management strategy, with a dedicated study lead, who will look to de-risk a study at every turn, whilst also demonstrating flexibility to be able to adapt to challenges that arise during the study
• Robust Quality Systems & Data Management: Possess a comprehensive suite of policies and processes for study management and have a secure and user-friendly EDC system
• Personalised approach: Large CROs may have a great track record and have a trial management infrastructure, however, often multiple large projects ongoing at any one time. This often means less time can be spent on individual client programmes, treat as a one size fits all approach. Smaller to mid-size CROS have the ability to offer a priority, personalised and customised service focusing in on the unique intricacies and workings of each client and project
• Patient Centric approach: Most importantly the best CROs will always focus on the welfare, safety and experience of a patient

In summary

Employing the services of a CRO can make a huge difference to the success of a clinical trial. Sponsors should carefully assess the specific needs of their projects and look for the CRO that best meets their technical requirements and budget.

Find out more about ARC’s CRO offering or get in touch to discuss how we can support your next development