The Role of CROs in Pharmaceutical and Healthcare Industry.

Although the CRO industry has existed for decades, it is now evolving faster than ever as competition rises between organizations and the demand for outsourced clinical services is increasing. As the drug development process is becoming more and more complex, the pharmaceutical industry leverages all the opportunities to make the process more efficient.

What are CROs?

Contract Research Organizations, or CROs, provide services for industries (pharmaceutical, medical device and biotechnology) who want to outsource operations. Among the services these organizations offer are project management, data entry and validation, data management of clinical trials, medicine and disease coding and much more, up to final study reports.

According to The Business Company Research, outsourcing to CROs is expected to grow at a CAGR (Compound Annual Growth Rate) of 7.4% by the end of 2019. The market is estimated to grow till 2021 and have a value of $44.4 billion. As stated in the study by Grand View Research Inc., the CRO market will reach $54.7 billion by the year 2025.

Although CROs outsource services for multiple industries, according to the estimation of the Association of Clinical Research Organizations, half of the CROs outsource services for the pharmaceutical industry.

CROs provide support in clinical research and trials, commercialization of products, pharmacovigilance, etc. Some organizations take care of almost all procedures, starting from clinical trials up to the approval of FDA (USA) and EMA (Europe) or other regional authorities that are in charge of approving drug products.

There are large CROs, which provide services internationally, relatively smaller organizations and niche-specific CROs.

CROs work as third-parties for clients that are called sponsors. Notwithstanding the fact that sponsors ‘hire’ contract research organizations to conduct researches, trials, etc., they are still the ones responsible for the factuality of data and how much it is backed by science. The budget is controlled by the sponsor and the planning is upon the CRO.

Because CROs performs so many functions and carry out so many procedures, the CRO team is naturally quite big and with multiple departments:

  • Department for Medical Trials: People in this department are qualified medical professionals that design clinical studies, assist in developing trial protocols, etc. Among the professionals under this department are clinical research physicians, medical consultant, etc.
  • Regulatory Submission Team: These are people who perform the submission of different documents needed for the outsourcing processes. This team is also responsible for getting the approval of the authorities. Submission team is very important for CROs, as without an approval the process cannot proceed.
  • Clinical Operations Team: This team comprises many people and is usually the largest within the organization. There are research associates, projects managers, trial assistants and many other professionals in this group. They are responsible for choosing the trial sites and assisting in the study management process altogether.
  • Data Management Team: This team is in control of the databases for data collection, as well as designing new tools that are needed during the process. No CRO can perform well without a proper data management team, as it provides well-organized data ready for the analysis.
  • Biostatistics Team: Biostatistics team analyzes the data to find out whether the results are positive or negative. On the basis of this analysis statistical tables are generated, which later serve as a source for medical writers.
  • A Team of Medical Writers: Medical writers convert the figures and tables produced by the biostatistics team and present it to the general public in a more perceivable way.
  • QA Team: The Quality Assurance department is responsible for conducting audits to make sure that all procedures are within the required standards. How this team operates has a very big impact on the overall quality of the CRO.
  • Training and Development Team: This department takes care of the constant development of the team members, organizes trainings and ensures that the staff does not fall behind the industry advancements.
  • IT department: No modern organization can operate without an IT team that will take care of all the problems concerning software, servers, etc.
  • Administrative and Finance Department: This team takes care of all the administrative processes of the organization, as well as performs finance related works.
  • HR Team: An organization having so many departments and a big staff obviously needs a proper Human Resources department to take care of talent acquisition and hiring new members.

Benefits of Working with a CRO

Drug development is a complex process that needs a lot of attention and resources. This is why it is quite wise to transfer the tasks related to drug development or clinical trials to a third-party CRO. Here are what benefits you can reap when working with a CRO:

  1. Saving human and material resources. Pharmaceutical or healthcare organizations, when developing drugs or conducting clinical trials, would need to hire a staff and certain professionals if it were not for CROs. In addition to this, they would need material resources such as material resources as proper equipment, building, etc.
  2. Saving money. This is the main reason why companies outsource to CROs. Conducting the whole process from start to finish on their own costs companies much more money than it does when certain functions are outsourced to a third-party.
  3. Saving time. Engaging a CRO into a drug development or a clinical trial process saves time for organizations and companies that naturally do not engage in such procedures. Even getting an approval from the regulatory authority will take more time than it does when CROs are incorporated. CROs are always ready and well-prepared for drug development in all its stages.
  4. Access to big data. CROs, in contrast to individual organizations and companies, have access to big data collected from multiple platforms and are able to use it more efficiently. When partnering up with a CRO, the sponsor makes use of all the resources that a CRO has, thus adding more value to the final product at a much lower cost.

Contract Research Organizations bring numerous benefits to the pharmaceutical, biotech and healthcare industries. With reduced costs, companies and organizations get a final product, the quality of which is higher than it would have been if the processes were not outsourced.

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