Starting clinical trials is not for the faint of heart. Recent research found that 72% of clinical studies run more than one month behind schedule – with the daily lost in market exclusivity costing up to $10 million.
Currently, 80% of trials fail to meet enrollment timelines, and up to 50% of sites enroll one or no subjects with subject recruitment days costing $1.3M per day. Cloud-based solutions such as clinical trial management systems (CTMS), electronic data capture (EDC), and the electronic trial master file (eTMF) are all quantum leaps in improving clinical trails, but their adoption rates vary. And significantly, they do not address one of the most inefficient and costly bottlenecks of clinical trial conduct – study startup (SSU).
Recognizing this Industry leaders are now adopting ‘best of breed’ applications in the eClinical stack to speed the development of needed therapies to patients.
Vittoria Sparacio, Head of Clinical Documentation, GSK Pharmaceuticals
Since 2008, Vittoria Sparacio leads Document Management and Archiving within Novartis Vaccines’ Development function. In this role she launched the division’s electronic Trial Master Files system and established new processes and standards in document management and archiving for quality and compliant clinical studies. Vittoria has also led inspection readiness programs, clinical operational excellence initiatives and contributed to the DIA TMF Reference Model working group. Prior to that, Vittoria held operational and scientific roles in Clinical R&D, in the Pharmaceutical and CRO industry beginning 2001. Vittoria holds a Master’s Degree in Molecular Biology from the University of Pisa, Italy, and had basic research experience in molecular genetics and immunology at the University of Gothenburg and Karolinska Institute of Stockholm, Sweden.
Scott McCulloch, Principal Consultant, SMClinical Limited
Over the past 10 years, Scott has worked for a number of Life Sciences service provision organisations including Veeva Systems, Trial Interactive (TransPerfect) and ClinTec International, where he has assisted small, medium and large Sponsors and CROs with business process re-engineering and organisational change, along with clinical development and commercialisation strategies.
Today, Scott has a black belt in Sig Sigma and works as Principal Consultant at his own consultancy firm SMClinical focusing on the provision of Study Start Up and Trial Master File Strategy and Management.
Barry Milton, Director of Client Engagement, goBalto
Barry is a clinical trial and operations management specialist. Prior to joining goBalto, he held numerous senior roles at Novartis, Paragon Solutions, Roche, Merck, and AstraZeneca. His passion is transforming study management and trial execution processes through the creation of facilitating systems and production environments, allowing teams to meet their patient and clinical program goals faster and more efficiently.
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goBalto develops next-generation solutions that simplify and accelerate clinical study startup in the Pharmaceutical, biotechnology, and medical device industries. Our management team has over 100 years of combined experience in the life sciences industry and enterprise software implementation. Our team has worked for such companies as Amgen, Genentech, Quintiles, Roche, Johnson & Johnson, and Model N. With a proven commitment to customer success, disruption, and study startup optimization, we’re changing the way our leading global pharma and CRO customers approach their business processes. Based in San Francisco, California, we have satellite offices in Pennsylvania and Singapore. For more information, visit www.gobalto.com.