Drug Safety & Pharmacovigilance Solutions for Life Sciences Organizations

Intrasphere delivers comprehensive drug safety, pharmacovigilance and risk management services and solutions.  We help Life Sciences organizations to plan, design and implement safety systems that facilitate regulatory compliance, manage risk, improve operational efficiency and ultimately ensure consumer safety. 

Our dedicated team of subject matter experts are Oracle® Argus Suite, Aris Global ARISg™ and Total Safety™ Suite product specialists. We boast over a decade of industry experience and have successfully completed numerous drug safety engagements at the world’s leading pharmaceutical and biotechnology organizations.

The Industry we Serve
Clients we cater to are involved in the clinical development, distribution and marketing of pharmaceuticals including drugs, biologics and vaccines, and/or medical devices.  We understand first-hand the strict local and global regulations that the industry operates under to ensure the production of safe and effective drugs.  As a result we partner with clients to develop specific proactive solutions that anticipate and address multiple safety scenarios, risks and contingencies.

Our approach for each engagement is to pursue our clients’ agendas, not ours.  Some of the comprehensive solutions we develop to help the advancement of drug safety operations for our clients consist of; data management systems, signal detection technologies, adverse event reporting systems, case processing and pharmacovigilance strategies.

Our clients are leading global pharmaceutical and biotechnology organizations that operate in North America, Europe and Asia. 

Intrasphere Sets the Standard
The Intrasphere Drug Safety practice is a highly regarded executive team of safety and industry subject matter experts who are globally accessible and specialists in the implementation of leading vendor solutions including the Oracle Argus Suite and Aris Global’s ARISg and Total Safety Suite, among other commercial systems. 

All of our seasoned professionals have hands-on experience in drug safety, clinical and regulatory fields and understand the complex industry challenges faced by clients. We have the breadth of domain experience and depth of technical competencies to help companies shape strategies and implement best practices.

Our Services Portfolio
We provide flexible solutions to lead and/or support client organizations through a range of projects including system upgrades, replacement of a safety system, merging of multiple safety systems, and initial safety system implementations, among others.  The projects we manage are broad in scope, require the highest levels of industry compliance, and are subject to rigorous validation procedures for installation, operational and performance quality.

Our full spectrum of services include:

• Safety System Advisory Services
  “What do other companies do?”  “What are best practices?”  If you find yourself asking these questions then we can help.  Our drug safety industry and subject matter experts are uniquely positioned to advise clients on industry trends and how regulatory changes/demands are being met.  Our in-depth knowledge of the Oracle Argus and Aris Global suite of applications enables us to offer solid advice, based on real experience, across a range of pharmaceutical and biotech client experience.
  
  
• Organizational Design
  Our Organizational Design services are built around our relevant pharmacovigilance experience to ensure best practices are highlighted while aligning with an organizations corporate culture, vision and strategy.  Services range from simple organizational assessments to more complex engagements to plan a new organization, leading the transformation.
  
  
• Safety System Assessments and Vendor Evaluations / Selections
  Whether you need to assess the efficiency of a current system, evaluate the marketplace or select a replacement system, we can help.  Our experts have a thorough understanding of industry leading products including; Oracle Argus, ARISg and Empirica Trace. 
  
  
• Safety System Implementation
  With extensive experience in safety system implementations Intrasphere provides flexible technology solutions to lead and/or support client organizations through a range of projects including system upgrades, replacement of a safety system, merging of multiple safety systems, and initial safety system implementations.  Our extensive knowledge of industry COTS and home grown systems allow us to guide clients through the full lifecycle of system design from configuration to data migration, from testing to deployment. 
  
  
• Safety Business Process Redesign
  The successful delivery of realigned organizational processes involves effective communication across all stakeholders through the preparation, testing, training and post implementation support phases.  Intrasphere leverages experience in all areas of delivery to provide or support implementation planning, test script development and execution, training material development, training delivery and post implementation support. 
  
  
• Integration Design
  Intrasphere has broad and deep relevant pharmacovigilance experience in the consultation of integration requirements with systems such as CTMS, DMS and ds Navigator.  We help clients to streamline processes and automate the exchange of information between disparate systems based on solid subject matter and industry experience.  We develop integration requirements and technologies that are specific to clients’ safety systems that detail user requirements as well as integration design, building and testing. 
  
  
• Analytics, Visualization and Reporting
  Regulatory inquiries, risk management, product defense and other drivers all require that companies can access and analyze their drug safety data on both a routine and ad hoc basis with flexibility and efficiency.  Intrasphere’s key knowledge of transactional systems, such as Argus Safety and ARISg, and reporting systems such as Argus Insight and agSignals offer clients a unique perspective on the challenges of maximizing these applications, working around constraints and producing output that meets pharmacovigilance business needs. 
  
  
• Training
  Our subject matter experts develop drug safety and related training strategies, materials and delivery of trainings as required.  In the simplest form trainings can center around system functionality or, in a more complex form, include client-specific configuration and SOPs.  Training sessions can be customized based on clients’ requirements to deliver. We specialize in Argus and ARISg and relations modules as well as general drug safety overview enabling new hires to get up to speed quicker.
  
  
• Online Reference Materials
  Intrasphere helps pharmacovigilance organizations to realize numerous business benefits by creating a central document repository where users have instant access to accurate, consistent and current information.  Our technology expertise with portal products such as Microsoft® SharePoint, allows us to provide clients with a total solution covering design from a business & technology perspective, content development and implementation.
  

Sample of Successful Client Engagements
Intrasphere has been engaged by leading pharmaceutical, biotechnology, CRO and medical device organizations to implement and deploy numerous safety applications.  To learn more about our comprehensive drug safety project experience, or, if you would like to get in touch with one of our client references, contact us.

Existing Relationships and Experience with Major Industry Safety Vendors
Intrasphere brings to every engagement an unparalleled depth of industry solution and product experience. Our partnerships and strong relationships with companies such as Aris Global and Oracle among others enable us to serve as a single source for clients’ drug safety and pharmacovigilance needs: