Advantages and Disadvantages of Contract Research Organizations
Many pharmaceutical companies have started using Contract Research Organizations to help manage clinical trials for new drugs. Using a CRO reduces the cost of clinical trials for drug approval. Pharmaceutical companies can pass those financial savings along to the customer. If you plan to contract with a CRO, it is necessary to understand the advantages and disadvantages of their services.
WHAT DOES A CRO DO?
A CRO is an independent agency that works with pharmaceutical, medical device, and biotechnology industries to perform clinical trials. They use information regarding your product to develop an electronic Trial Master File. This eTMF for emerging biotech is the critical component for your projects. An eTMF is an application designed to store clinical study documents on the cloud. Both the CRO and you should maintain the ability to monitor this information throughout the entire trial.
Most CROs specialize in the type of services they offer, so it is critical to understand the scope of your project before you contact the company for a quote. They manage all aspects of the trial, from coordination, planning, and execution. A CROs typical services include:
- Planning of the clinical trial
- Monitory federal or local regulations
- Selecting the site
- Recruiting clinicians and participants
- Coordinating trial logistics and medical writing
- Ensuring quality project management
WHAT REGULATORY AGENCY DOES IT REPORT TO?
You remain the responsible and sponsoring company. The CRO is monitored and inspected by the FDA. Ultimately, your firm is responsible for maintaining the standards of your clinical trial. Established CROs are experienced in helping you develop the most cost-efficient procedures that meet FDA guidelines.
WHAT ARE THE ADVANTAGES OF USING A CRO?
New and established pharmaceutical firms would contract with a CRO to perform clinical trials for many reasons. Hiring a CRO means you employ a full contingent of professionals. You do not need to acquire equipment, hire medical writers, or locate participants. The CRO already has the machinery, medical writers on staff, and resources for gathering local participants. These resources provide immense cost savings for your business.
One often overlooked advantage is using a global CRO. Every nation requires that pharmaceutical companies run clinical trials in their country. Global CROs already have established relationships in international markets.
WHAT ARE THE DISADVANTAGES OF USING A CRO?
Establishing a clinical trial with a CRO has some challenges also. If this is your first clinical trial with the CRO, or you are hiring them for a different type of trial, you should perform small audits before releasing them to begin the project. These audits ensure the CRO has the tools and resources to complete the contracted work. It can cause slight delays before you get the project rolling. If the CRO cannot fulfill your company’s requirements, you must repeat the process and look for another provider.
In addition, even with procedures in place, you lose some control with every task you turn over to a CRO. Remember, if your trial is rejected for any reason, including a failure by the CRO, your pharmaceutical company will have to accept the consequences. Most CROs know their responsibility to their client, but your contract must have contingencies if they fail to perform their duties.
WHAT CRO SHOULD I HIRE?
If you have decided to work with a CRO, look for a company with experience in your field. Interview two or three companies to determine which best meets your company’s needs. Look for a firm that provides information about past and current trials while maintaining their clients’ confidentiality. They should also have experience with the FDA and other regulatory agencies.
Find a CRO with whom you can build a relationship. Talk with the key team members and find out their primary communication styles. Be sure they are responsive to your questions or concerns. If the CRO fails to respond promptly to your inquiries during your inquiry stage, you will likely experience similar challenges during the trial.
Strategically hiring a CRO can help you move your products through clinical trials more efficiently and at a lower cost than doing it yourself. While your organization is capable of performing clinical trials, a CRO may be just the resource you need to get your product to market on time.
