“Access to clinical trials improves patient outcomes”
Biopharmaceutical companies have been working for years to reduce cost and improve the timeliness of the research and development process. In spite of these efforts, it remains time consuming and costly to develop new drugs. Today the process takes 10-15 years at an estimated cost of $1.318 billion.
In 2005, it was reported that delays in clinical development of new treatments was in part due to the conduct of its research studies. On average, 66% of all studies performed are delayed for 2.7 months and 39% report that site selection is the principal delay.
TRM is developing a solution to delays in drug development by creating a SinglePoint™ nationwide, qualified pool of community oncology sites ready and able to test new treatments.
How TRM Can Help
- Rapid Identification of Research Sites and Study Launch
The TRM network will accelerate development for each research study through rapid site identification and by matching each study with the most qualified site, standardizing CTA’s, allowing for a single point budget negotiation, and providing a rapid IRB Review/Approval resulting in timely patient enrollment.
Providing Quality Sites for Research
TRM collects site specific information and qualifications, provides each site with regulatory materials, provides education and training to the sites, and establishes contracts with ancillary service providers. TRM will implement integrated EMR/Practice Management systems with clinical trials for each site.
Streamline Management of Research Studies
For drug developers, efficiency and effectiveness of information processes can directly impact their speed and ability to test new treatments. TRM provides study start-up services, regulatory support (including IRB submissions, amendments and continuing review) and billing services that accurately reflect pre-approved, contracted budgets.
TRM is committed to improving the entire drug development pipeline to control clinical trial costs with pre-negotiated ancillary service provider rates, invoiceable costs and coordinated accrual. The entire process is also streamlined through orders that match the sponsor protocol, integrating EMR/EDC systems to allow physicians time to focus on critical patient issues and, ultimately, create an environment of more personalized medicine.