A Contract Research Organisation (CRO) provides research services to the biotechnology, pharmaceutical and medical device industries through a contract agreement. CROs have various functions and specialities. Ultimately, they operate as a hired agent that carries out specialised tasks for a trial sponsor. Any data that a CRO collects should be unbiased and meet the regulatory requirements which are then used in a participant-driven approach to drug discovery and device design.
CROs originally started out working for pharmaceutical companies by managing clinical trials and analysing toxicology evaluations. Today, they carry out more complex tasks which revolve around tissue engineering, pharmacokinetics (study of drug absorption and distribution), pharmacodynamics (the study of the biochemical and physiological effect of medication), and the biocompatibility of implants.
CROs offer specific services relating to discovery, pre-clinical, clinical and laboratory services. More than one CRO Lab can be hired at the same time - depending on what services they specialise in and the geographical area they cover.
A CRO’s Services
CROs offer a large range of services, including the following:
- Site selection and set-up
- Site management
- Regulatory affairs
- Data management
- Logistics management
- Medical reporting and writing
- Project management
- Chemistry and biological expertise
- Data entry and validation
- Data processing and management
- Clinical trial participant recruitment
- Medicine and disease coding
- Safety and efficiency reports
- Marketing help
- Statistical analysis of reports and plans
- Study report review and submission
- Database design and build
The main roles found in a CRO include:
- Project managers
- Research assistants
- Site contract managers
- Quality managers
- Clinical research associates
- Clinical trial assistants
- Regulatory affairs managers
- Heads of clinical operations
- Data managers
- Statistical programmers
Some CROs will focus specifically on certain areas while others will offer a wide range of services.
There is a general increase in sponsors who are recruiting CROs to help them throughout the clinical trial process. CROs play an integral role in all aspects of the development stage, especially in Phases I, II and III of clinical trials which can take anywhere from three to six years. All the responsibilities are put down in writing which means that CROs are legally liable for carrying out all the jobs that they’ve been assigned.
Before a clinical trial gets underway, the CRO will need to recruit participants for the different phases. They will need to know how humans react to different treatments and make note of any side effects that appear. Before the drug is submitted for approval, the CRO will organise the data and write up the study results. Even after the drug has been approved to go on the public market, the CRO will keep testing the drug’s safety and effectiveness to ensure that it remains safe for public use.
What Are the Benefits of Using a CRO?
There are many advantages of outsourcing work to a CRO, including:
- Pharmaceutical companies can put all their focus on the development process of the clinical trial, while the CRO does all the other work, including all the stages of clinical trials.
- CROs have experience and previously established systems to deal with project management, data collection and patient care and can efficiently complete the work.
- Hiring a CRO saves time and money. With a CRO by the pharmaceutical company’s side, the clinical trial sponsor will lower the overall costs of a clinical trial.
- CROs are ready to begin the work as soon as a contract is signed.
- CROs will have experience and awareness of the international medical and research markets and knowledge of the different regulations in each country.
- Strategic alliances with CROs build trust and leads to an open dialogue around clinical trial details and priorities. This allows research teams and pharmaceutical companies to be able to resolve any issues with the assistance of a diverse business culture and operational systems.
- CROs have knowledge of the best clinical trial investigators and sites in a specific location which allows for high participant enrollment numbers.