Last week we exhibited at and attended CBI’s clinTECH 2013 conference, which focused on how to "Implement, Manage and Integrate Systems to Advance Clinical Trials". The focus of Day 1 of the conference was the overall eClinical suite of capabilities, and Day 2 featured systems-related tracks for CTMS, Clinical Portals, eTMF and EDC, with the morning of Day 3 covering Clinical Cloud. In attendance from Paragon was the Clinical and Regulatory Optimization Practice Team, and Paragon sponsored the eTMF track Day 2.

It was an interesting approach to a conference, and a direction that we think is an unmet need, although many attendees were disappointed with having to choose between very interesting presentations on Day 2 depending on the track, especially with eTMF and Portal running in parallel. But ultimately the direction of the joint meeting is the right way to go for the future, as focusing on the “silos” of clinical systems causes unnecessary issues in both system interoperability and business process alignment.

Interoperability was a HUGE thread of interest and focus in the first day. Barbara Tardiff, Vice President of Development Operations and Global Head, Clinical Informatics and Innovation at Pfizer, Inc, gave an excellent keynote presentation on the Intersection of Technology and New Clinical Research Operating Models. She spoke on how there is a need for an interconnected clinical trials ecosystem, referring to clinical trails management as being similar to a baseball team (a theme that the remainder of the conference speakers tried to emulate!).

Ms. Tardiff called out several market pressures as game changers in the Clinical technology landscape (what Paragon refers to as the Clinical Architecture), including mobile tools in healthcare, Electronic Health Records as a source and integration, and subjects as significant participants (fulfilling the role of “personal data scientist”) and leveraging public domain “big data” health information to evolve from descriptive to predictive clinical trials and analysis. Ms. Tardiff outlined the Pfizer use of data on a Phase 4 study, in order to predictively model enrollment based on inclusion/exclusion criteria. Great ways to pro-actively assess the ability to recruit based on the study model!

Another big theme at the conference was the potential value and impact on the industry of initiatives and consortiums like TransCelerate BioPharma, leveraging collaboration amongst sponsors, in order to optimize business processes and technology investments that are not a competitive advantage. TransCelerate seeks to advance innovation in research and development (R&D), identify and solve common R&D challenges and further improve patient safety, with the goal of delivering more high quality medicines to patients. TransCelerate will accomplish these objectives through its focus on identifying and capturing efficiencies in the clinical trial process, which will reduce costs, increase speed to market, and enhance quality, innovation and patient safety.

It was great to get an update on the current collaboration projects, and to hear from the TransCelerate CEO Dalvir Gill on his thoughts on how to push forward initiatives, with a strong focus on execution to timelines.

There was significant discussion in particular about the Portals collaboration project, with the initial goal being to deliver Single Sign On (SSO) across the member companies, and some base functionality (document exchange, aggregated notifications, alerts and tasks among them). Mr. Gill mentioned that it was initially thought the Portals project was going to be the most progressed project, but the difference in member company maturity in the Portal business capabilities forced a bit of a reset on focus and scope. He also mentioned that if agreements and progress were not made, the best option could prove to be either dropping it or putting the project on hold, in order to re-focus resources on projects which are progressing to the executional goals.

The Portal initiative is an ambitious effort, and one that the industry has unsuccessful history from prior attempts such as CRIX. We see this as a great opportunity to focus on the business process challenges, and develop a framework of capabilities, rather than working toward a truly common technology application architecture across the wide spectrum of member organizations. The diversity of current capabilities amongst the member companies brings the risk of forcing compromise to the deliverable to such a point that no one’s needs are met. Additionally, with the wide resources at the TransCelerate table, it is also an critical oppotunity often neglected in life science technology development to ensure all the Portal user community needs are a high focus: bring investigators to the table to get the “what’s in it for me” value proposition met. To be visionary, it would be ideal to also consider the just-around-the-corner requirements of the patient “data scientists”.

We have significant hope and confidence in the work being done on the Risk Based Monitoring project. The goal in this initiative is to deliver a common framework and methodology for Risk Based Monitoring, as opposed to a common technology platform. The project team has submitted a draft whitepaper to both the FDA and MHRA for feedback, and the intent is to publish the final whitepaper for all of industry to leverage.

In our next blog post, we will deep dive on the content provided in the various tracks, starting with eTMF.

Creating a Roadmap to Clinical Trial Efficiency