Contracting in the pharmaceutical industry is an important component of the CRO, which conduct clinical studies for medicines. The leading pharmaceutical and biotech company, which has partnered with CRO for clinical research, expects the overall level of research to a 68% increase by 2023.
Most CROs conduct clinical trials and clinical support for drugs or medical devices and transfer FDA or EMA marketing permits from a new drug or device to consumers without any Sponsor staff support. According to CenterWatch, there are more than 1,286 CROs worldwide, some with annual revenue of $ 7.4 billion.
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Choosing the right CRO for a clinical trial can be an important decision for a successful program. If more than one CRO is selected, what evaluation criteria should be used? In many ways, choosing a CRO is no different than choosing other vendors. However, the relationship between the CRO and the Sponsor has its own shades.
British BioMedicine Clinical Trials (BBMCT)
You can easily differentiate CRO with the following eight categories.
№1 Portfolio experience and service
When reviewing a CRO, you should evaluate the company’s experience and, most importantly, their experience in your therapeutic field. Find out the lyrics of the song and their feedback from the clients. Ask about specific clinical studies they have worked on. Different stages of drug development require different skills. The first phase is very fast, and the third phase may be very challenging.
Then evaluate the company’s employees in terms of quantity and quality. If the scale of this clinical project is large, the number of employees will be important. If field experience is required for a project, the quality of staff (number of doctoral students, etc.) may be a concern. Find a team structure that will be given to you and check the support given by the management.
Find out more about what CRO has to offer. CROs, which offer a wide range of services in a variety of medical settings, may be ideal for many research companies. On the other hand, depending on the needs of the study, choosing specific CROs with experience in different areas of treatment may be the right decision. New directions for opening and expanding key opportunities should also be considered.
№2 Financial stability
CROs, by their very nature, deal with significant business risks because their work involves developing products that will be approved and eventually sold. Clinical trials can be canceled at any time for a variety of reasons, so a CRO should address the industry uncertainty you choose without adversely affecting your project. Ask the CRO how long it has been in operation, and there are sufficient financial resources to assess whether the project documents are large enough to reduce the “traffic forecast”.
№3 Structure, procedures, and systems
The CRO infrastructure of a project is important to meet the needs of your project, so if the CRO you are looking at is well equipped and meets the needs of the project, you should carefully review their efforts. Staff is ready to discuss your project. Ask what program they are using to monitor project performance and how the clinical information system is set up. Yes! Are medical records kept in accordance with Section 11 21 CFR? Yes! What steps do they need to take to transfer data stored in a CRO to your company’s system? Is the transaction secure? Yes! What process does the CRO use to facilitate the review of medical information? Yes! How does a CRO conduct basic research?
№4 Access To Hospital And Subjects
One of the benefits of using CRO is that they can access specific investigator sites and patient groups that are not in your company. This type of information is facilitated by “production” sites, that is, sites with a proven track record of testing patients and providing better patient information.
The most important factor in choosing the anticipated rate of subjects. PI often overlook for patients who meet the inclusion criteria for recruitment from time to time. Make sure your CRO has documentary evidence to prove the accuracy of patients who meet the tight exclusion and inclusion criteria.
British BioMedicine Clinical Trials (BBMCT)
№5 Worth
While reasonable spending may be the preferred choice in CRO partnership, it is not the key to choice. Quality guidance and service assistance will provide additional guidance. Depending on the way the project is being considered, the costs can be maximized. For smaller companies, costs may be more certain but focus on fewer claims, which may indicate that the legal decision is uncertain.
Not considering the importance of the work or the resources required for the project. Better CROs have senior management and a budget that needs to be finalized at the same time. Also, keep in mind that expenses are not only a financial hassle but also a source of income for you.
№6 Transparency
What do you want to do for transparency? Most sponsors feel they have a clear idea of their experience and goals, so they know that transparency is not enough for their CRO list. If your list of options is more transparent, it should always be filed and monitored at the recommended time. You can increase access to the needs of CRO experts in relationships. The sponsor’s description allows for proper maintenance without the need for additional equipment. Full transparency of operation and patient data will help increase additional services and budgets as needed.
№7 Collaborative Partnership
Another often overlooked criterion is the ability of sponsors to work with real CRO. Working with different people means different things, so it’s important to evaluate how members of your CRO team do the clinical study when dealing with them.
Assess the level of leadership and responsibilities of the CRO team leader by giving specific examples of how the team has addressed technical issues in the past. Hello! Do you have the same goals? Hello! Did they invest in credibility and research success? If the CRO team feels responsible for ownership control, the relationship acts as a true partnership and the process will run smoothly.
British BioMedicine Clinical Trials (BBMCT)
№8 Real-Time Sensitivity
As everyone knows, a quick answer to a problem or question can be the difference between a quick solution and an uncontrolled problem. Don’t just focus on judging a CRO team based on a lack of technical skills and required business skills. Short-term delays in making corrective decisions can lead to costly consequences such as protocol changes, overruns, and additional patient recruitment.
Such decisions must be made immediately so that management is unaware of important missing events. The ability to make quick decisions based on the latest information and patient performance data is a quality that needs to be valued in order to reach the full potential of the CRO/Sponsor relationship. Ensure that both CRO & Sponsor are fully integrated team members to be able to receive real-time information and adapt to unforeseen events that occur during the clinical study.
CONCLUSION
When evaluating a CRO, you must adopt a rigorous and disciplined approach that includes both tangible and intangible items. A qualified CRO will have the experience and expertise of its area, to be financially stable, to understand real collaborations, to show flexibility and resilience to change in real time. A good CRO is also easy to implement with the right course management and documentation that helps sponsor achieve the best possible clinical trial results.
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