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As the pharmaceutical industry grows and evolves, so do outsourcing models in clinical research. It is estimated that by 2020, contract research organizations (CROs) will conduct close to 75% of all clinical trials. Among CROs, there is a broad range of services offered, functional strengths and regional expertise; all of which affect how trials are carried out.
Global vs. Local CROs: Weighing the Benefits
Sponsors often choose to work with global CROs when offshoring clinical trials, particularly for multinational studies. Larger organizations are better equipped to conduct global studies, but they can also lack specialization in important areas, especially when it comes to location. This is why many global CROs choose to outsource certain clinical trial services to smaller, local CROs.
There are a few areas in particular where local CROs can have a significant positive impact on a trial’s conduct.
Strengths of Local CROs
Recruitment and Enrollment
Recruitment and Enrollment
Research shows that in the United States, around 90% of clinical trials are delayed because of enrollment challenges, and only 7% meet the projected number of participants on time. These setbacks are extremely costly — site selection issues alone increase the cost of a clinical trial by at least 20%.
Local CROs are often better equipped to handle patient recruitment and enrollment requirements for locations around the world. Native, on-the-ground staff can mean faster access to treatment-naïve patients, and relationships with principal investigators and site networks. A local CRO’s extensive knowledge and experience in a single country or region can help accelerate study start-up timelines and site activations, and prevent overspending, better positioning the study for success.
OCT Clinical Trials operates in Russia, where according to a report by the FDA, patient enrollment ranks second only to the United States.
OCT’s local expertise has led to highly successful enrollment for international studies. In a phase III ovarian cancer study, OCT recruited over 44% of all patients and achieved over double the enrollment rate than that of the rest of the world. This is a common pattern for CROs like OCT, and offers a strong example of how global studies can benefit from the help of smaller, local organizations.
Regulatory adherence is perhaps the most challenging aspect of clinical development. In order to obtain FDA approval, drug sponsors must file a new drug application (NDA) with data to support its safety and effectiveness.
However, since over half of all clinical trial sites are outside of the United States, FDA application procedures must take place alongside international regulations.
Requirements for internationally sponsored studies are becoming stricter with time. Having a local CRO partner with deep knowledge of the local regulatory environment is a significant advantage, resulting in fewer roadblocks and faster approval timelines.
OCT is proud to have achieved a 100% Clinical Trial Authorization (CTA) rate across its countries of operation. Learn more about how OCT helps sponsors navigate the regulatory submissions process in Russia.
Rescuing Struggling Trials
Rescuing Struggling Trials
Delays in clinical trials can cause revenue losses between $600,000 and $8 million per day. Rescue efforts are critically important to sponsors who find themselves behind on a trial, or with a CRO who cannot fulfill part of a trial. Partnering with smaller, local CROs who bring a specialized knowledge and understanding of an area is extremely beneficial.
Large, global CROs are often focused on running massive trials. They can fall short of providing each trial in its portfolio the time and dedication needed to move it to an efficient close. Partnering with nimble and more cost-effective local CROs can give a trial — and its in-house team — the one-on-one project management attention it deserves.
OCT has an outstanding track record of conducting rescue efforts for trials that have fallen behind on time and resources. The process starts with a thorough review and assessment of all study elements and identification of key issues that are causing the trial to struggle. Then, OCT develops a study rescue plan and an expedited schedule to get it back on track, regaining lost time and momentum. Thanks to this type of assistance, sponsors — and other CROs — achieve much greater success with their trials.
Trends in CRO Services and Outsourcing
Trends in clinical trial services are pointing toward more complex outsourcing arrangements that involve multiple CROs and other vendors. As analytics technology improves, for example, outsourcing decisions will depend more and more on metrics, performance and predictive data. This opens opportunities for smaller CROs to provide niche services in key areas, like those we’ve just described.
Strategic partnerships allow global and local CROs to offer a higher caliber of clinical trial services, creating better outcomes for sponsors. When supported by a network of specialized CRO partners, global CROs better position themselves to serve pharmaceutical and biotech companies looking to offshore their clinical trials, and looking to get their life-changing treatment to market.
Learn why OCT Clinical Trials could be the right choice for your outsourced clinical trial needs.
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