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| home > white papers > Driving ROI: The Case for Investing in Contract & Site Regulatory Document Management Services - DrugDev |
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 WHITE PAPERS |
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DrugDev
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Driving ROI: The Case for Investing in Contract & Site Regulatory Document Management Services
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With tight timelines and complicated regulatory documentation requirements, getting a clinical trial up and running quickly is easier said than done. Key milestones can be achieved only after the successful negotiation of clinical trial agreements and completion of essential regulatory documents. Many clinical trials are hindered by inefficient, labor-intensive processes. Prolonged, inefficient activation can hamper investigator satisfaction and, ultimately, have a negative bottom-line impact for sponsors and CROs. In addition, the Sunshine Act is heightening the importance of financial disclosure in clinical trials. Without a robust financial disclosure strategy, sponsors cannot ensure that physician self-reported financial disclosure data are aligned with the payment data being reported through the Sunshine Act, increasing financial and regulatory risk.
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News and Press Releases |
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Validation batches of the vaccine against equine strangles Strangvac® is completed
[Noáin, January 27, 2020] 3P Biopharmaceuticals, a leading CDMO specialized in the process development and GMP manufacturing of biologics has, together with the Swedish biotechnology company Intervacc AB and LIOF-Pharma (previously Praxis Pharmaceutical), completed the manufacturing process for the vaccine against equine strangles called Strangvac®. The validation production batches required for the forthcoming registration application to the European Medicines Agency, EMA, are thus finalized.
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White Papers |
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Clinical Trial Site Contracting: The Conservative, Progressive and Hybrid Models
DrugDev
For the last 20 years, pharmaceutical companies have turned to a variety of clinical outsourcing solutions to reduce costs and improve timelines, enabling them to focus on their core value of research and development. In today’s tightly competitive market, companies are constantly striving for ways to further cut costs and reduce study startup cycle times, while maintaining quality.
One of the key cost factors in global R&D spending, estimated at around $102 billion per Kalorama market research, is the cost of conducting clinical trials. CRO’s, which account for about 30% of the total R&D spending, have risen to the challenge of the clinical, technical and administrative management of these trials. But some pharmaceutical companies question how much control to relinquish to vendor partners, especially in the legal arena, due to potential ramifications.
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Industry Events |
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ESMO Targeted Anticancer Therapies Congress 2020
2-4 March 2020, Paris, France
A unique and international mix of experts, researchers and decision
makers both from academia and industry across the globe, will convene
in Paris for a three-day Congress aiming at exchanging knowledge,
experience and research innovations in cancer.
TAT
2020 will focus, among others, on novel strategies in immuno-oncology,
personalised medicine and molecular tumour boards, preclinical studies
to identify effective combination therapies, use of microbiome, tumour
agnostic trials, ADC technology, oncolytics, multispecific biological
constructs and targeting cytokines.
Participating in TAT 2020 will offer you the possibility to take part in
interdisciplinary discussions inspiring new ideas and new
collaborations.
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