INDIANAPOLIS--(BUSINESS WIRE)--YourEncore, a leading provider of technical expertise to the life sciences, consumer health and nutrition industries, today announced a program to help pharmaceutical companies improve the quality of clinical trial data included in regulatory submissions.
“Incomplete or inaccurate data can delay or jeopardize regulatory approvals,” said Tim Franson, M.D., YourEncore’s Chief Medical Officer. “We bring years of experience, advanced expertise and fresh eyes to help companies identify and correct problems, keep approvals on track, and improve processes for future submissions.”
Ensuring the quality of clinical trial data can be a challenge for drug and device makers. Data are often based on trials from patients and investigators across the globe. Time and resource constraints and multiple vendors with disparate systems and standard operating procedures can also increase the likelihood of errors.
YourEncore helps improve clinical data quality across all stages of clinical development and submission:
- Pre-Trial Quality by Design. Experts evaluate processes, controls, metrics and timelines to identify potential impacts to data quality. They peer review and refine clinical programs and protocols to ensure data quality is designed into trials from the start.
- Data Quality Monitoring During Trials. Teams review clinical data to identify and address issues and gaps, and develop recommendations to improve data integrity, compliance and organizational efficiency.
- Submission Preparation and Response. YourEncore data review teams have been called on to assess causes and remediate data problems identified by regulators after submission.
Given the long lifecycle of drug development, many in the industry may only work on 1 or 2 submissions in their entire career. YourEncore brings many years of collective experience, therapeutic-area expertise and objectivity to companies at critical times.
“Flaws in data can cost millions of dollars and undermine the confidence of regulators, investors and providers, and delay getting lifesaving therapies to patients who urgently need them,” said Franson. “The right expertise at the right time can keep products moving through the pipeline and get products to market faster.”
Indianapolis-based YourEncore helps companies in the life sciences, nutrition and consumer health industries speed new products to market; improve quality, safety and compliance; and enhance productivity. YourEncore experts have on average 25 years of experience and are behind many of the most innovative products on the market. In addition to advisory services, the company also offers the resources to act on its recommendations. Founded in 2003, YourEncore today works with 12 of the 15 leading global pharmaceutical companies and 4 of the 6 top consumer care companies. For more information, visit www.yourencore.com and follow www.facebook.com/yourencore.