Sciformix To Showcase New Clinical Research and Post-Approval Support Capabilities at DIA Clinical Forum

1 Oct 2013
Kerry Parker
CEO

Product news

The new SLIM™ Operational Model delivers excellence in scientific and operation efficiency

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 .
To learn more about Sciformix visit www.sciformix.com , email us at ask@sciformix.com, or call us at +1.877.576.5005.

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ADME-ToxicologyADME-toxicology (ADME-Tox) studies are used in pharmacology and pharmacokinetics to assess the activity/toxicity of drugs <i>in vivo</i> or <i>in vitro</i>. Find bioassays for absorption, distribution, metabolism, and excretion of drug molecules including cytotoxicity, transporter/permeability, metabolism and activity assays as well as hepatocytes and cell lines for ADME. Find the best ADME-toxicology products in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.Clinical TrialsClinical Trials, an essential part of drug discovery process, assess the safety and effectiveness of a new medication or device in the pharmaceutical industry. Clinical Trials are a phased process (Phase 0, Phase I, Phase II, Phase III and Phase IV) which begins after initial preclinical testing.RegulatoryPharmaceutical regulations impact on all areas of drug development, manufacture and control and supply. Services are provided from the early stages of drug development and clinical trials through to dossier submission, approval and marketing. Regulatory also includes submission of analytical studies from the pharmaceutical product and safety. Clinical StudyProspective biomedical or behavioral research studies on human subjects, following tests in animals, that are designed to answer specific questions about novel vaccines, drugs, treatments, dietary supplements, devices or new ways of using known interventions, generating safety and efficacy data.Drug DevelopmentDrug development refers to the process of bringing a new drug to market.
Sciformix To Showcase New Clinical Research and Post-Approval Support Capabilities at DIA Clinical Forum