New Frontiers in Clinical Trial Data Collection

Last week, Quanticate, a CRO specializing in data-related clinical services based in the UK and US, announced its partnership with Clinical Ink, an eSource provider based in the US. That partnership brings Clinical Ink’s SureSource platform to Quanticate’s CliQ (Clinical Intelligence from Quanticate) portal.

I spoke with Quanticate executives Michael Whitworth, VP of Centralized Clinical Data Sciences, and Christine Cramer, VP Clinical Data Management, as well as Clinical Ink’s Global Director of Sales and Marketing, Chris Ramm about the partnership, EDC and eSource, and the current state of technology solutions in clinical trials.

Quanticate’s CliQ portal is the technology backbone to its CSP approach, or Centralized Service Provision. CSP is considered its next-generation Functional Service Provision approach by Quanticate since it focuses not just on functional outsourcing but also on the efficiencies of centralizing tasks across the data collection lifecycle. Whitworth described it as the company’s goal of providing clients with centralized data collection, access, analysis and visualization tools they require to manage the lifecycle of Phase I through Phase IV clinical trials. “It really is a way to access clinical data regardless of where it has been collected and in what format through a single portal,” said Whitworth. Having the ability to analyze data across studies, programs and portfolios can provide significant reductions in development costs and timelines to enable quicker submissions.

Like much of the clinical trials world, while EDC has been adopted to improve clinical data collection, the next generation of eClinical tools is hoping to provide leaps into transparency and decision-making for CRO and sponsors alike. Cramer noted that the SureSource integration into CliQ will allow the company to “leap on data quickly and make decisions quickly.” For example, she said that having the data quickly available and transparent will allow companies to make a dose escalation study decision more quickly, saving time in the overall drug to market process. “As a CRO, the portal brings data immediately to the sponsor,” said Cramer.

SureSource, as described on the Clinical Ink website, is a tablet-based solution that allows “validated source data to be entered on protocol specific eSource documents that retain the look and feel of paper forms. The source data and documents can then be managed, viewed and stored” in a secure web portal.

Ramm noted that SureSource has received numerous awards this past year, including this year’s “Gartner’s 2012 Cool Vendor List for Life Sciences”, Microsoft’s Life Science Innovation Award with Novartis, and most recently, its receipt of the 2012 “Data Driven Award” from the Society of Clinical Data Management.

For Clinical Ink, the partnership with Quanticate is a great fit, according to Ramm. “We see that the traditional roles of data management and monitoring becoming more overlapping or entwined. Our eSource/Remote Monitoring Platform truly enhances their strong suit in these areas as well as, allowing them to internally take on the monitoring role for the studies we conduct together. Jointly, will be able to offer a solution for sponsors that will dramatically reduce their costs, and drive efficiencies, which is not possible using the traditional EDC methods of today."

As a data-focused CRO, Quanticate operates as a globally-capable CRO, but as its roots are in the UK, they have a strong grasp of the European clinical trials market. Both Whitworth and Cramer observed that eClinical technology adoption rates are similar in both Europe and the United States. However, they do see more data technology and newer solutions coming from the United States.

And as far as regulatory concerns with eSource documents, Ramm noted the company’s close relationship with both the FDA and EMA in regard to its acceptance and has the backing of both to promote real-time data capture. “Both agencies are making really good progress in a positive manner,” said Ramm. Cramer added that with the different regulatory authorities across the EU, most have generally adopted technology progress.

Whitworth said that the data capture and storage itself is similar because of standardized data structures, as supported by CDISC. However, with more diversity of technology solutions, the sponsors and CROs do face having different technology processes and having a method to centralize, visualize and analyze all this data is important to optimize R&D. He believes that initiatives such as TransCelerate will help data standardization moving forward.