PharmaVigilant Selected by Trevena, Inc. to Support International Study
PharmaVigilant Integrates their InSpire EDC and I-Vault (eTMF) solutions to Support Studies in North America and Europe
WESTBOROUGH, Mass.--(BUSINESS WIRE)--PharmaVigilant, a clinical trial technology provider, has been selected by Trevena, Inc. to support an International clinical trial with its integrated InSpire EDC and electronic Trial Master File (eTMF) solutions. Trevena is utilizing PharmaVigilant's solutions to support the preparation, conduct and closeout of an international trial across both North America and Europe.
According to David Soergel, M.D. Vice President and Head, Clinical Development Trevena, Inc., "When we set out to select a technology partner, we knew we needed a solution that would be able to execute the integration process quickly and effectively. The flexibility with PharmaVigilant's solution for both EDC and I-Vault (eTMF) was an important factor. Their technology has been able to easily scale to multiple complex global studies and I am confident their solution will help us expedite our study timeline and remain within budget."
"I applaud Trevena as a forward thinking Company that understands the strategic implications of investing in an eTMF system early on because as regulations continue to squeeze sponsors for greater accessibility to data, Trevena will be well positioned to respond to the increasing regulatory demands," said James DeSanti, Founder and Chief Executive Officer, PharmaVigilant. "The work we're doing with Trevena has been an ideal model to fully maximize the flexibility and scalability of our technology."
PharmaVigilant offers a full suite of clinical trial technology offerings including Electronic Data Capture (InSpire EDC), study building (I-Builder), electronic Trial Master File system (I-Vault eTMF), automated site payment system (PaySite), remote Source Document Verification (I-Vault rSDV), study administration (InSpire Control Center), data warehousing (I-Warehouse) and (I-Monitor), our total solution for sponsors and sites.
About Trevena:
Trevena is a clinical stage pharmaceutical company based in King of Prussia, PA, dedicated to the discovery and development of the next generation of G- protein coupled receptor targeted (GPCR) medicines. Established in early 2008, Trevena was created to translate groundbreaking research on GPCR signaling into a new generation of medicines. The company recently initiated a phase 2 program with TRV027, its lead program, as a potential treatment for acute heart failure.
About PharmaVigilant:
Based in Westborough, Mass., PharmaVigilant is an eClinical company providing fully integrated solutions for clinical development. Our suite of site/sponsor centric software and services automates the collection, management and analysis of clinical trial data and most importantly provides data transparency on demand, with total sponsor control. Sponsors rely on us to ease the regulatory and FDA submission and approval process and ultimately go-to market more quickly with top quality drugs. For more information, visit www.pharmavigilant.com.
Contacts
PharmaVigilant
Meghan Morrissey, 508-475-4222
[email protected]