Designing and carrying out clinical trials has remained relatively unchanged over the last 10-20 years; most biopharmas outsource their studies to a single contract research organization (CRO). The CRO then manages most aspects of the clinical trial, including the collection and management of all data.
While there is nothing inherently wrong with this model, there are significant benefits to enlisting the help of a Biometrics CRO to work alongside your Clinical CRO partner, particularly as it pertains to Data Management.
In this white paper, we discuss the benefits of partnering with two CROs- one for your clinical needs and the other specifically for Biometrics, and have outlined 5 key advantages below.
Advantage #1: Consolidation of Data
Sponsors often choose their CRO partner based on the unique needs of the clinical research which varies from study to study. While this makes perfect sense in terms of access to specialized expertise, this can pose a challenge when it comes to biometrics. Data gathered during clinical research is often siloed within the CRO’s proprietary system and housed inside of varying, incompatible software programs, which makes accessing and analyzing data very difficult.
By partnering with a biometrics CRO, your data remains separate and in one place across all studies, no matter which clinical CRO fits the needs of any given study. This results in streamlined data management and clinical analysis; Should a question arise about clinical programming, database development, or anything else data-related, you can easily reach out to one point of contact and gather insights quickly.
Advantage #2: Access to Specialized Expertise
Large CROs tend to excel in managing clinical operations, like patient recruitment and site monitoring. Biometrics CROs, on the other hand, specialize in statistical analysis, data management, and clinical data reporting. Partnering with a clinical CRO and a biometrics CRO gives you access to both sides.
Leveraging the strengths of both parties makes it easier to achieve high-quality outcomes. Not to mention, it helps lighten the load by divvying up crucial responsibilities. In a dual CRO situation, each organization can focus on its area of expertise without stretching itself too thin or navigating subjects it’s unfamiliar with.
Advantage #3: Efficient Resource Allocation
Partnering with two CROs can also be an efficient allocation of resources, saving you time and money.
Partnering with a biometrics CRO may save you time through a “divide and conquer approach” – your clinical CRO can focus on identifying trial sites, patient recruitment and enrollment, while the biometrics CRO can lend its expertise to data collection, data management, and statistical analysis.
When both organizations hone in on their areas of expertise, it’s easier to meet trial deadlines and boost efficiency. And, improved efficiency often translates to improved patient satisfaction and faster study completion, which ultimately saves you money.
Advantage #4: Quality Assurance and Compliance
Partnering with two CROs adds an additional layer of quality assurance and oversight to your research. Bringing a new drug or therapeutic to market is a Herculean effort, with an immense amount of data to collect and interpret.
With two CROs you can establish a system of checks and balances. More specifically, each contract resource organization can independently check the work of the other, reducing the risk of mistakes or oversights. This offers several benefits, including:
- Enhanced data accuracy and integrity
- Adherence to all regulatory requirements and industry standards
- Improved quality control
- Better risk mitigation
- Quicker study completion
Considering that the average phase 1 clinical trial costs $4 million, even minor quality assurance and compliance improvements can result in major savings and peace of mind.
Advantage #5: Mitigating Vendor Dependence
Don’t put all of your eggs (or data) in one basket when conducting clinical research. Problems are likely to arise at some point during your relationship with any given CRO, considering the amount of moving pieces involved in clinical research; high turnover, lack of expertise and poor communication are among the common concerns. In extreme cases, when issues are persistent and/or insurmountable, sponsors may be forced to terminate their relationship with their CRO mid-study, causing a host of challenges and delays, with the transfer of clinical data being one of the most disruptive.
However, if you have a separate CRO partner for biometrics, your data would remain consistently stored and easily accessible, making the transition to enlisting a new Clinical CRO far smoother. While becoming a “rescue Study” would still sting, at least your data would remain unscathed.
Diversifying your vendor portfolio helps maintain progress even if challenges occur. This approach offers flexibility and options in the event of unforeseen circumstances.
Conclusion
With clinical research becoming increasingly complex, rethinking your approach to CRO partnerships is worthwhile. Rather than relying on a single organization to handle all aspects of the study, dividing the responsibilities between a clinical CRO and a Biometrics CRO has multiple benefits, including having all of your clinical data stored and managed in one place, improved efficiency and increased control over your data.
As a biometrics CRO, Harbor Clinical offers a streamlined solution to data management. To learn more about our capabilities, visit our website and fill out an online contact form or email [email protected]. A member of our team will reach out to you to schedule a brief consultation so that we can learn more about your needs.
