It’s simply unfair to ask a team of humans from a standard Contract Research Organization (CRO) to perform this task accurately. An average CRO does not have intelligent tools to assist the pharma industry in this critically-important task.
Cincinnati, Ohio (PRWEB) July 31, 2014
ClinGenuity of Cincinnati, Ohio has developed an automated redaction management service using its artificial intelligence engine to meet the growing demand for pharmaceutical clinical trial disclosure and transparency initiatives.
And big pharma has jumped on it.
Having already processed more than a half billion redactions, ClinGenuity clearly has unsurpassed experience in this critical area, said Keith Kleeman, ClinGenuity founder and CEO.
“We’re seeing significant growth in the market due to our unique redaction technology, workflow and service in addition to our other services and technologies,” said Kleeman. “Our clients are some of the largest and most well-respected pharmaceutical companies globally, as well as several of the founding members of TransCelerate BioPharma, Inc.”
TransCelerate BioPharma is a nonprofit organization founded in 2012 to improve people’s health worldwide by accelerating and simplifying the research and development of innovative new therapies and medicines. Members include some of the largest pharmaceutical companies in the world.
Of critical importance to pharma is determining how best to react to and be compliant with both external clinical trial transparency mandates such as European Medicines Agency’s (EMA) Policy 70, and also internal corporate transparency mandates, both of which are extremely difficult to deliver, said Kleeman. These transparency initiatives have at their core the distribution of previously confidential clinical trial data for public consumption.
However, prior to complying with transparency and disclosure initiatives and providing these documents to the public, sensitive personal and patient-protected information must first be accurately identified and securely redacted from regulatory documents, he added.
An average document for disclosure, or Clinical Study Report, is about 10,000 pages. Considering there are approximately 600 words per page, that’s an average of six million words per study report. Larger pharmaceutical companies doing the minimum to be compliant with Policy 70 would typically need to redact a minimum of 25 clinical study reports per year, or roughly 150 million words each and every year, said Kleeman.
“Finding names, email addresses, patient ID numbers and other sensitive information is like looking for a needle in a haystack,” he said. “It’s simply unfair to ask a team of humans from a standard Contract Research Organization (CRO) to perform this task accurately. An average CRO does not have intelligent tools to assist the pharma industry in this critically- important task.”
ClinGenuity’s Redaction Management Service, the pharmaceutical industry’s only automated solution, solves these problems by combining artificial intelligence with domain expert, clinically-trained quality control reviewers using proprietary secure tools that assist in managing workflow and rules associated with the transparency initiatives.
“Almost every client we’ve worked with attempted manual solutions, but quickly found that there were accidental disclosures of sensitive information.” said Kleeman. “Our model is to manage the process through the use of intelligent automation that ties rules between automation and human review so that the common failures in consistency and accuracy are alleviated.”
ClinGenuity is fast becoming the pharmaceutical industry’s gold standard for transparency and disclosure.
“Simply put, we are the most accurate and efficient solution, and as a result we greatly reduce the risk of accidental disclosure and the liability that goes along with such a mistake for our valued clients,” said Kleeman. “It’s hard to believe, but our competition is sometimes as basic and outdated as humans armed with black markers. We are excited to be such an integral part of this new era of transparency in the pharmaceutical industry, and are proud to assist our clients in this most critical endeavor.”
For more information on ClinGenuity, go to http://www.clingenuity.com or call (513) 239-6918.
Contact: Keith Kleeman
Phone: (513) 239-6918
ClinGenuity, a Cincinnati-based medical writing company using expert medical writers assigned to each project according to expertise, has the only artificially-intelligent tool in the pharmaceutical industry. ClinGenuity increases new drug and medical device development efficiencies to help reduce development cycle times and costs.