By Janice Chang, senior VP, global operations, TransCelerate BioPharma Inc.
The evolution and complexities of drug development have prompted biopharmaceutical organizations to seek collaboration much earlier in their research and development (R&D) programs and better appreciate the value of collaboration in areas such as study planning and start-up. These arrangements are becoming critical to business strategies for many in the industry hoping to create greater efficiencies and advance the R&D of innovative medicines. One key factor that is driving the success of these collaborations is the willingness and commitment to share information such as study materials and training documentation.
In September 2012, some of the world’s leading biopharmaceutical companies formed the non-profit organization TransCelerate BioPharma, Inc. with a vision to improve the health of people around the world by accelerating and simplifying R&D. By building model frameworks and other deliverables for certain components of clinical research, TransCelerate has sought to address industrywide challenges such as clinical trial monitoring, site administration, and quality management, while meeting a strategic priority of exchanging information to reduce the burden on sites, investigators, and patients, and enable sponsors to bring medications to market faster.
As the pace of clinical innovation has increased, so has the complexity of clinical trials. Biopharma companies conduct multinational studies while trying to meet the ever-changing regulatory requirements — yet the time and effort to bring new treatments to market remains long and intricate. During study planning and start-up, clinical trial sponsors invest significant time and resources in identifying qualified investigators and establishing the quality of study sites. As the study progresses and study activities are executed, data is collected from a variety of sources, and in different formats, leaving a substantial burden on sites and sponsors to manage it all while remaining compliant.
To address this need, TransCelerate launched the Shared Investigator Platform (SIP) Initiative, which aims to provide the biopharma industry with a centralized, open-architecture platform that’s interoperable with both emerging and existing clinical solutions. The core capabilities of the SIP are focused around streamlined information sharing such as feasibility surveys, facility profiles and study documents, data collection, and communications between investigators and participating sponsors, as well as reducing redundant requests during a trial to improve investigator experience.
The SIP helps participating sites and sponsors solve some significant operational R&D challenges that are common to trial sites and sponsors. Most importantly, SIP benefits the patient by reducing the amount of time investigators dedicate to onerous administrative tasks, redirecting their focus instead on the patient experience — which is a critical element to a trial's overall success.
Emerging technology has changed the nature of R&D for the better, and TransCelerate is embracing the benefits its convergence with clinical development will have on R&D programs. In addition to introducing functionalities such as single sign-on within the initial release of the SIP, TransCelerate most recently announced the integration of a cloud-based content management solution with SIP to enable participating sponsors and sites to easily access and exchange information during clinical trial execution. Clinical research sites often must use written documents to perform clinical trial responsibilities for each sponsor with whom they work. As a result, communication for sites that work with multiple sponsors and across multiple studies has been cumbersome and complex.
In this new world of connected health, streamlined information sharing can be a powerful advantage – it gives an organization the ability to effectively drive solutions that are tested and tailored. Fortunately, the success of the TransCelerate collaborative model so far, and its emphasis on information exchange across the clinical ecosystem, suggests a more streamlined and efficient clinical environment is imminent.
About The Author:
Janice Chang currently serves as the senior VP of global operations of TransCelerate BioPharma Inc., and its subsidiary, BioCelerate.
TransCelerate is a non-profit organization with a mission to collaborate across the biopharmaceutical research and development community to identify, prioritize, design, and facilitate the implementation of solutions that drive efficient, effective, and high-quality delivery of new medicines, improving the health of people around the world. As a member of the senior leadership team, Ms. Chang works closely with the CEO and the board of directors to execute the strategic vision, spearhead TransCelerate’s key operational plans and activities, and ensure delivery excellence across TransCelerate’s entire portfolio of nearly 20 initiatives.
Ms. Chang is a seasoned industry executive with career experience in large pharma, biotechnology, and outsourced service environments. In these roles, she successfully championed strategic, transformational programs by implementing processes and technology solutions to drive dramatic improvements in operational performance. She is an expert in business strategy, cross-stakeholder collaboration, program management, business process improvement, change management, and operational excellence.
Read more about TransCelerate BioPharma Inc., leadership, mission, and Initiatives at: http://www.transceleratebiopharmainc.com.