1st October 2013 Sciformix Corporation, a leading Scientific Process Organization (SPO), will showcase its end-to-end capabilities in Clinical Research and Post-Approval Support Services (CRPASS), including the new SLIM™ Operational Model for post-approval and late-phase studies at booth #14B at DIA Clinical Forum, being held October 8-9 at the Dublin Convention Center in Dublin, Ireland. In addition, the company’s practice head for CRPASS will share her insights and experiences in the presentation on “The Importance of Patient Registries and Their Application in Emerging Markets”.
Incorporating Sciformix’s comprehensive experience in partnering with clients in CRPASS, the SLIM™ Operational Model forms an integral part of Sciformix’s post-approval support service to ensure clients optimize their products’ success and full potential in the marketplace. SLIM™ incorporates seamless end-to-end support from clinical trial start-up to close-out, lean and flexible processes, an IT and EDC enabled secure and compliant platform, and multi-functional expertise provided by a team of clinical operations specialists, statisticians, programmers, medical experts and writers.
SLIM™ is employed to support a wide range of post-approval studies including non-interventional studies, investigator-initiated research, epidemiology studies, and patient registries. These services focus on gathering real-world data to enable clients to have a better understanding of their products’ long-term safety issues and to meet specific regulatory requirements. These services form part of Sciformix’s comprehensive suite of offerings to be showcased at DIA Clinical Forum, including other offerings such as medical information and communication support, and market and competitive intelligence.
The presentation by Dr. Samyuktha Ajay, Practice Head for CRPASS at Sciformix, will take place on Tuesday, October 8th from 9:00 to 10:30 AM. Dr. Ajay will discuss the importance of Patient Registries in contributing towards access to better and safer treatments and informed decision-making for patient care and healthcare policy in the developing world. As an important element of risk management within an integrated drug safety program, Patient Registries provide the real-world data that complements the body of evidence obtained during clinical development and aid informed decision making.
Dr Ajay comments: “We understand how the operational requirements of Patient Registries and other post-approval studies are different from those of clinical trials and also understand the challenges in emerging markets. Sciformix offers best-in-class expertise in conceptualizing and designing registries and post-approval studies using the SLIM™ model to address the operational challenges. We have seen a lot of interest and success with this approach. ”
As this year’s overall theme “Rebooting Clinical Development” suggests, Europe and the rest of the world is entering a new era in Clinical Development, largely in response to substantial challenges the pharmaceutical industry has recently faced with respect to the increasing costs and decreasing success rates of clinical trials. Emphasis on emerging markets, post-approval studies and virtual trial management are a few key areas the industry is focusing on to address these challenges. Sciformix offers solutions in these areas, and partners with clients through the entire drug development cycle to provide a broad range of services from study design to post marketing surveillance and commercialization support.
To meet with us at DIA and/or receive a copy of the presentation, contact us at Bizteam[.]sciformix.com or call us at +1.877.576.5005
For further press information please contact: Susan Najjar, Director of Marketing, Sciformix Corporation: P: +1 617-264-0339 - E: susan.najjar[.]sciformix.com.
Sciformix Corporation (sciformix.com) is a leading Scientific Process Organization (SPO), providing scientific knowledge-based services to pharmaceutical and biopharmaceutical, generics, consumer products, medical devices and other healthcare companies - in the areas of Safety and Risk Management, Clinical Research & Post-Approval Support and Regulatory Affairs. Our mission is to partner with global life science companies to provide high quality scientific knowledge-based expertise to deliver better quality outcomes and improved efficiencies across the entire product lifecycle with the ultimate objective of improving quality of healthcare for patients worldwide. Corporate headquarters is located in Westborough, MA with operations in USA, India and the Philippines.
We create value for our clients through our singular focus on the life sciences industry, strong pharmaceutical domain competency, exceptional subject matter expertise, industry reputed advisory board, uncompromising focus on quality, process rigor, predictable results, and ability to scale. Our portfolio of services spans the full spectrum of product lifecycle from pre-clinical and clinical to post marketing activities to help our customers solve complex analytical challenges, improve the quality of patient healthcare and increase client productivity.
Sciformix is dedicated to providing our clients outstanding services and solutions, fueled by an unrivaled commitment to quality. We share the same level of involvement, dedication and passion as our clients and become an integral part of their team. Our distinct combination of scientific expertise, process rigor and technology innovation delivers consistent, reliable and insightful results. Our ability to scale and grow to meet your evolving needs means we are flexible and dedicated to your success in delivering safe products with more efficiency and greater speed. We help you make the right decisions at the right time by providing Trusted Services Built on Science.