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Easing the tribulations of trials

A Jersey City firm helps pharmaceutical companies and medical device makers meet data disclosure requirements

The regulatory process can be grueling for a company trying to get a new drug or medical device to market. TrialScope, a seven-year-old Jersey City-based firm, is making the road a little easier to navigate. The company helps clinical trial sponsors make clinical data available outside of their organizations.

With increased risks, complexities and costs associated with clinical trial disclosure, TrialScope executives contend that some companies are seeking to centralize, strengthen and streamline their trial disclosure processes.

Thomas Wicks, chief strategy officer, TrialScope.

“That’s the core of what we do from a technical perspective,” Thomas Wicks, chief strategy officer told NJBIZ.

“But we also help support communicating with patients by taking trial information and re-packaging it in a way that has been suitable for the patient community and meets their expectations and their information needs.”

TrialScope works primarily with biotech and pharma companies and some device organizations that are conducting clinical trials.

Wicks said that the company is also looking to work with academic researchers — anyone who runs clinical trials and is required to make data publically available.

“It can be for regulatory reasons or tied to funding mandates. It can also be to engage with patients and provide summaries to patients of the trials they’ve been in or information for patients to understand what are their options in terms of treatment,” said Wicks.

TrialScope enables clinical trial sponsors to consistently comply with evolving legislation and internal policies; improve global disclosure processes; efficiently track, manage and respond to clinical data requests and maintain control over and insight into dynamic disclosure content, processes and compliance programs.

Blue-chip client list

TrialScope’s clients include some of the world’s largest pharma companies including GlaxoSmithkline, Novo Nordisk, Pfizer and Novartis.

Sandi Marchese, director global clinical disclosure office for Novartis, said that the company has been happy with the level of service provided by TrialScope.

“Anything we need is answered timely, and when something is extra important to me, it’s handled accordingly. Attention from support, account management and even the high-level analyses that TrialScope performs for our benefit, all provide Novartis the confidence and ability to be as transparent as possible,” said Marchese.

Jennifer Van Ekelenburg, head of Clinical Governance and Data Transparency for GlaxoSmithKline, said “TrialScope listens to their customers and are very responsive to feedback.”

In the current clinical landscape, there are about 200 countries in which trials are run and about 90 of them have disclosure requirements stipulating that data about clinical trials must be made publicly available.

In addition, Wicks said, there are about 40 trial registries that are referenced in these 90 countries as the place where data must be disclosed.

“And across all of these registries there are no common requirements that mandates the same data be disclosed at the same time. It becomes very complex,” he explained.

From a regulatory perspective, companies have to make sure that they are compliant.

“That’s where we come in. We make sure that that process is efficient and compliant,” Wicks said.

The challenge, he added, is that some trial registries like clinicaltrials.gov and others are not good sources of information for patients who do not have a strong scientific background because of the data that is collected and the way it is displayed.

“It presupposes a relatively sophisticated degree of health literacy and ability to browse web sites that aren’t necessarilyy super intuitive,” Wicks said “Companies are recognizing that if they want to communicate with their patient community that’s simply no longer good enough.”

TrialScope is now building web sites that support the distribution of trial information to patients and the public in a language and format that is meaningful and easy to understand.

“That is a growing area. In the last two or three years there has been a great deal of interest in patient engagement and it’s rapidly moving away from concept in to reality,” Wicks said.

Increased scrutiny

In addition to mandatory publication of clinical data, what has changed in the last two years is the increased level of scrutiny by industry watchdog groups where individual studies are assessed for compliance.

“On top of which national health authorities have now started auditing or inspecting for compliance with these regulations and that is driving some change in behavior,” said Wicks. “It is uncomfortable to be listed publicly in a way that is unflattering or unfavorable.”

Wicks said that the entire industry, especially the leaders, are shifting how they communicate with patients.

“That’s where we are seeing a lot of uptake. Trial sponsors are interested and engaged in doing this and doing it well because there are real tangible benefits not just being ethical or being responsible, but there are also some metrics to back that up to say that having these kinds of web sites and communicating directly with patients is valuable.”

Anthony Vecchione, senior reporter, NJBIZ
Anthony Vecchione
Anthony Vecchione covers health care for NJBIZ. You can contact him at: Avecchione@njbiz.com.

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