Pharmacovigilance Onsite Services

www.sciformix.com

Pharmacovigilance Functional and Technical KnowledgeWhen You Need It

What’s Unique About Sciformix’s Onsite Services (SOS)?

The ultimate goal of pharmacovigilance, ensuring patient safety, has remained constant, but the methods, required knowledge, and regulations designed to reach this goal are continuously being updated and optimized. Adding to this inherent complexity, pharmacovigilance also involves the coordinated interaction of multiple business functions (literature search, call center, single case management, medical review, aggregate safety and signal detection), technologies (call center solutions, safety database hosting and maintenance, gateway implementation for electronic submissions and workflow specific automations) and global stakeholders (patients, healthcare professionals, pharmaceutical companies and regulatory authorities).

These factors, combined with the complexity and rigor of the requirements of global regulatory agencies, have resulted in companies investing more in patient safety for both their pre-market product approval process as well as post-marketing benefit-risk evaluation andmitigation strategies.

A significant challenge life science organizations face today is how to effectively implement an integrated human resource model that combines subject matter expertise in all aspects of safety and risk management activities, including technology solutions, to enhance productivity, compliance and quality. Companies that recognize the importance of such an integrated strategy will see greater success in managing the lifecycles of their products. Implementing and supporting an effective pharmacovigilance human resource model is difficult because it requires a diverse set of skills and expertise. As a result, many companies have employed a 3-teir resource model that consists of internal employees, project based pharmacovigilance outsourcing and onsite resources via a services partner.

Whether our clients require a single resource to provide on-site service, or a team working under their management, Sciformix can tailor the most effective onsite solution for each sponsor’s unique situation.

Sciformix is uniquely positioned to be your pharmacovigilance partner for onsite services. Our pharmacovigilance functional and technology experts in call center, case processing, medical review, aggregate reporting and signal detection, will be engaged in understanding and quickly selecting the “best-fit” staff for the requirements of your team. Our team will ensure the highest levels of quality and speed in reacting to your specific needs as well as ongoing change.

Sciformix’s Onsite Services (SOS) help life science companies build and maintain functional and technical operations across the safety & risk management continuum, including applications and enterprise portals for safety analytics. Additionally, we can provide experts in business intelligence, analytics, query and reporting, validation and regulatory compliance. This enables innovation and continuous improvement across the entire product life cycle and helps organizations to be more pro-active in their ability to respond to upcoming issues, challenges, and business needs.

www.sciformix.com

Sciformix Corporation1500 West Park Drive, Suite 210Westborough, MA 01581. USAPhone : 1 (877) 576-5005 Fax : 1 (508) 302-6520Email : bizteam@sciformix.com

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Sciformix Corporation is a leading scientific knowledge-based organization that provides process, technology and consulting services to the life sciences industry. We collaborate with our clients through the entire product development lifecycle to provide a full range of services from study design to post marketing surveillance and commercialization support.

Trusted Services. Built on Science.

Sciformix is uniquely positioned to be your pharmacovigilance partner for onsite services. Our pharmacovigilance functional and technology experts in call center, case processing, medical review, aggregate reporting and signal detection, will be engaged in understanding and quickly selecting the “best-fit” staff for the requirements of your team. Our team will ensure the highest levels of quality and speed in reacting to your specific needs as well as ongoing change.

Sciformix’s Onsite Services (SOS) help life science companies build and maintain functional and technical operations across the safety & risk management continuum, including applications and enterprise portals for safety analytics. Additionally, we can provide experts in business intelligence, analytics, query and reporting, validation and regulatory compliance. This enables innovation and continuous improvement across the entire product life cycle and helps organizations to be more pro-active in their ability to respond to upcoming issues, challenges, and business needs.

Our TeamWith over 600 employees dedicated to our Pharmacovigilance practice, Sciformix’s onsite consultants are highly qualified in their respective functional and technical areas. They also have access to our global organizational knowledge that spans a wide variety of regulatory and therapeutic expertise. Whether you need additional long-term expertise for specialized tasks, or a shorter term team to assist with projects, Sciformix can supply you with the knowledge, skills and experience you require.

Our Global ClientsSciformix has extensive experience for over a decade, working with small, medium and large organizations in life sciences and healthcare, providing niche and end-to-end expertise across the entire safety, risk management and technology continuum.