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TRANSCRIPT
TransCelerate aspires for a future state where research and development is faster, more efficient, and harnesses all the available information. We envision this happening in 3 ways:
1. Full participation across all stakeholders -- clinical trial sponsors, sites, investigators, patients and their healthcare providers
2. Information is fully used to improve the overall quality, design and development process. We protect patients through shared, proactive safety science
3. Improving the execution of research and development through greater harmonization with the potential to conduct collaborative trials
NEWEST RESOURCES
PROGRESSPULSETHE
ON
TransCelerate’s Realization Summit welcomed more than 500 attendees, including keynote speaker Dr. Janet Woodcock, representing more than 25 countries and 19 Member Companies. Read a full recap here.
Q3 2018 HIGHLIGHTS
Q3 2018 HIGHLIGHTS
THE PULSE ON PROGRESS
Information Sharing & Harmonization
Enable the industry to move toward greater harmonization of process and facilitate the sharing of information amongst industry stakeholders to enable the industry to capture, optimize and experience efficiencies.
Since the release of our new global technology platform, DataCelerate, we’ve received a positive response from the industry. Here are some of the top media highlights:
• “R&D Data Sharing: Where We Are & Where We Need to Go,” by Virginia Nido, Global Head, Industry Collaborations at Roche
• “New Data Sharing Platform—DataCelerate—Aims to Improve Clinical Development,” featuring Mike Graziano, Vice-President, Drug Safety Evaluation at Bristol-Myers Squibb
• “How TransCelerate’s Clinical Data Sharing Platforms Are Improving Clinical Development,” featuring several TransCelerate and Member Company executives
Q3 2018 HIGHLIGHTS
THE PULSE ON PROGRESS
Improve the Patient & Site Experience
Improve the patient and site experience by decreasing burden, enabling a better-informed patient and improving clinical research awareness, participation & engagement.
• The Investigator Registry Initiative recently launched the Data Query System (DQS) 2.2, which builds upon existing functionality to support sponsors with evidence-based country/investigator identification and more accurate timeline planning based on robust study metrics. DQS also benefits consenting investigators, as their professional experience and qualifications are visible to 13 participating Sponsors to enable site selection for clinical trial opportunities.
• The Shared Investigator Platform (SIP) announced Release 3.0, introducing new capabilities within the SIP. The latest release significantly enhances the platform, allowing users to migrate all ongoing studies on to the SIP platform, giving companies the ability to manage their full portfolio of studies. Release 3.0 also expanded the Invitation and Registration workflows to allow for mass onboarding, a critical enabler of scale for the SIP. In addition to these deliverables, the platform continues to see great momentum in implementation:
» 11,200+ registered site users across 78 countries
» 145 active studies
» 2200+ mutual recognition GCP certificate approvals
» 340+ feasibility surveys executed
Q3 2018 HIGHLIGHTS
THE PULSE ON PROGRESS
Enhance Sponsor Efficiencies & Drug Safety
Facilitate the advancement of innovative healthcare and clinical research through improved technologies, advanced data collection systems and simplified processes.
• The Interpretation of Guidances & Regulations Initiative published a Letter to the Editor in Clinical Trials, titled, “Global pharmacovigilance regulations: Call for re-harmonization.” The piece poses a call to action for regulatory authorities to work with sponsors to identify potential ways to re-harmonize global pharmacovigilance processes and requirements.
• A new study from the Value of Safety Information Data Sources Initiative on the impact of patient support programs (PSPs) on overall pharmacovigilance operations piqued the European Medicines Agency’s (EMA) interest at the agency’s 14th industry stakeholder platform meeting. Read more about the study results and what they may mean for the pharmaceutical industry in this article.
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