The combined companies will now include more than 200 regulatory and medical writers with expertise in document development for the US FDA, EMA (European Medicines Agency), and other regulatory organizations, as biotech and pharma companies increasingly look to outsource their medical writing work.
Artificial Intelligence
As far as how medical writing will be influenced by AI, Synchrogenix CEO Kelley Kendle, told Outsourcing-Pharma.com, “There has been a need in the drug development space for some time for a technology solution, not to replace writers, that will never happen, but to enhance efficiencies and optimize the talents that our level of writers bring to the industry.”
And since “there is a tremendous amount of repurposing of information, and because organizations are siloed and programs exist over long periods of time, sponsors are burdened with a tremendous amount of rework which can present opportunities for errors. As a result, we see inconsistencies and/inefficiencies in this process,” Kendle said.
The AI engine and technology from ClinGenuity “represent content re-use done intelligently,” Kendle added, noting that they “are not structured content tools – those have proven to create many challenges as processes change… We saw the AI platform as a unique solution to this challenge, with the ability to automate some of the rudimentary tasks that writers and editors are often plagued with, that quite honestly minimize their contribution to the overall strategic purpose of the document(s) for the various audiences.”
Kendle predicts these new tools will increase the time writers can spend honing messages and concentrating on the areas that will have the highest impact and require expertise.
“The AI platform is unchallenged in the area of redaction – there is not another solution out there,” she added. “The industry’s commitment to disclosure and transparency is increasing, and to truly support that growing commitment, you must have a tool that can guarantee the protection of patient-identifiable information.
Transparency Efforts
As new European and US clinical trial data transparency initiatives come into effect and create new disclosure compliance requirements for pharma and biotech companies, companies are looking to new solutions to help them redact and de-identify datasets in their clinical study reports and submission documents, produce research summaries suitable for a lay audience, and publish their clinical study information publicly.
“As there are more regulations and more demands for clinical information either from the regulatory agencies or from other stakeholders, including patients, the pharma industry is burdened with managing risk and resources,” Kendle added. “The more places this information resides, the greater the disclosure risk, due to the number of individuals that need to touch the information and repurpose it. This introduces inconsistency, inaccuracy and a potential breach of disclosure. Putting a solution in place for all transparency requirements is imperative.”