You don't know what you don't know—when it comes to navigating the potential risks and problems associated with international clinical trials, this statement speaks volumes.
At OSMOS, we believe that knowledge is paramount to smart, profitable business decisions. We have spent years researching and acquiring real-life expertise in order to determine the benefits and challenges specific to each region. We customize our services to achieve three main objectives:
1. To keep you as informed as possible before you make your most important decisions;
2. To give you control with thorough oversight and project-specific quality assurance measures; and,
3. To ensure reliable results.
We work hard to help you streamline your effort and save time and money along the way.
One of our European clients asked us to help them verify the results of a feasibility study for their upcoming project in Eastern Europe. According to the CRO, there were plenty of eligible subjects who satisfied all the inclusion/exclusion criteria. However, after our local experts double-checked the findings, we found that in fact none of the subjects met one very specific inclusion criterion and thus would not be eligible for participation for at least another year and a half. As a result of our own feasibility study we identified another location within the region that did have the subjects our client was looking for. Based on this information the Company was able to save a significant amount of time and money by placing their study in a location that produced reliable and rapid enrollment.
BE INFORMED: ADVISING AND NEGOTIATING
Depending on the specifics of your project, we advise our clients on where, how and with whom to conduct their clinical trials. If you have not yet decided where you want to conduct your clinical trials, we can help you select the most appropriate region. Our assessments and in-depth feasibility studies ensure that you have all the information necessary to make an educated decision and avoid enrollment delays.
Once you have chosen a location, we will work with you to select the most suitable partners for the project, from multinational or local CROs to a central laboratory and any other vendors required for the project. OSMOS will create detailed requests for proposals and submit them to as many potential vendors as necessary. We will suggest companies from our prescreened list and assess additional companies you might have identified. Finally, we can play a critical role in negotiating costs and terms with these vendors to ensure that you receive the best value for your money. Experience has proven that this type of business intelligence has a significant impact on bottom-line results.
Because of our extensive experience on numerous projects around the world, OSMOS has a unique understanding of what clinical research trials should cost. We know how different vendors in different regions structure their contracts and price their services. Recently, a North American client approached us to help them assess and negotiate budget proposals they received from their vendors for an upcoming Phase III global study. After carefully reviewing the details, we uncovered a number of areas where our client was either being overcharged or the proposed services were not critical for the successful execution of the project. Working together with our client we suggested alternative vendors for some services and we re-negotiated the terms and budgets of the existing proposals. In the end, we saved our client over $2 million from the original proposal without any reduction in the amount or quality of work to be performed.
MAKE SURE: CO-MONITORING AND AUDITING
As a part of the selection process, we recommend that you pre-qualify your potential vendors through an audit. We also suggest that you audit your trial early to ensure it is being conducted properly and to catch any issues before they escalate. That’s when our co-monitoring and auditing services become critical.
OSMOS has conducted numerous audits in the U.S., Russia, Eastern Europe and other parts of the world. We are strong proponents of performing co-monitoring and auditing in foreign countries with highly trained quality assurance (QA) professionals who are either local native speakers or fluent in the language of the country where the audit is conducted. These experts understand all the intricacies of the medical culture and documentation they are dealing with. They speak and read the language and do not rely on translations to conduct detailed, unbiased, and truly independent audits.
Over the years we have identified, trained and employed native-speaking medical and QA professionals in many emerging markets around the world. This allows us to respond to our client’s requests rapidly and to assure them that their projects are being monitored without the significant expenses associated with international travel and use of interpreters. OSMOS experts have the hands-on experience to deal with the most difficult situations and produce in-depth, reliable assessments expeditiously and cost effectively.
In 2008, OSMOS responded to an emergency call from a U.S. pharmaceutical company. Data coming in from an ongoing trial was suspicious. There was a possibility of fraud, which would have meant the data from the affected site—almost 10% of the worldwide sample—might be compromised and have to be discarded. An OSMOS expert from the U.S., fluent in the local language, went immediately to the region, where he was joined by local experts to investigate a potentially devastating situation. After conducting a thorough audit, OSMOS was able to identify a single and discrete point of failure at the site. Fortunately, this failure explained the data abnormalities and proved that there was no fraud. Once corrected, the trial was back on track and the company was able to preserve months of work and save millions of dollars.
Contact us and find out how you can benefit from our services around the world.
© 2010, OSMOS Clinical Research, Inc.