Creating a New Formula for Drug Safety and ComplianceIntrasphere acquisition enhances R&D Informatics in life sciences |
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Blending the synergies of its leading life sciences R&D practice with a drug safety consulting market leader, Deloitte has acquired Intrasphere, a global drug safety and regulatory consulting business. The transaction includes PharmaCM®, a content management platform for life sciences organizations which enables the clinical trial information registration process.
Market trends such as, the growing impact of health information technology and social media, increased complexity of therapeutic offerings in the marketplace and an increasingly complex and stringent regulatory environment, are creating an impetus for more proactive product safety and regulatory support services. The addition of these capabilities to the Deloitte life sciences consulting portfolio enhance our ability to help clients improve their product safety, signal intelligence, pharmacovigilance and regulatory information management capabilities.
"Intrasphere brings deep proficiencies in drug safety, pharmacovigilance and regulatory capability to complement our existing life sciences and research & development practice enabling us to expand our ability to create market-leading strategic solutions in this space for our clients."
̶ Dan Ressler
Principal, Deloitte Consulting LLP and Life Sciences R&D Informatics Leader
Solutions and Services
Drug safety technology and solutions
Drug safety is critical in the drug development process. Activities in this area are being driven by a growing interest among regulators, consumers and the medical community. The need for safety management has risen dramatically over recent years and as a result, companies should substantiate that they are taking appropriate steps to pursue drug safety within the context of regulatory requirements. An integrated approach to risk management including adverse events collection and , processing and reporting helps companies demonstrate, both to consumers and regulators, their data/analytical capabilities and a commitment to drug safety. Our combined capabilities span a broad spectrum of business and technology solutions in the drug safety space. Service offerings focus on providing our clients with tools designed to enhance signal intelligence, analytics and reporting and online reference tools. This is accomplished through the planning, design and implementation of drug safety data warehouses, portals to track and manage adverse events, applications to manage remote data capture and assembly of periodic reporting for regulatory agencies. These initiatives typically include a combination of re-design of existing business processes with the technologies to enable them.
Our technology solutions include guiding our clients through the vendor evaluation process for drug safety management systems, implementations of these systems and migration of data from legacy applications and development and management of electronic submissions tools (E2B). In addition, we provide a detailed analysis toolkit to help our clients measure and manage pharmacovigilance risk.
Regulated Content Management
(PharmaCM®)
The process of developing Bio-Pharmaceuticals and medical devices is an information intensive endeavor. Companies face an enormous challenge in managing and harnessing the value of content contained in countless documents generated across a variety of departments throughout the product lifecycle. Additionally, companies must comply with ever changing government agency regulations as well as finding new ways of reducing drug development costs and introducing products in a timely manner.
PharmaCM is a regulated content management solution which can help users identify and address ineffective content authoring and management and distribution processes, including Clinical Trial Registration.
PharmaCM’s Clinical Trial Registration module helps companies not only gather accurate clinical trials information, but also manage the complex process of authoring, reviewing, approving and uploading study content to ClinicalTrials.gov. Upcoming releases will enable life sciences companies to do the same with the European Union’s Clinical Trial Register. Users can establish appropriate workflows and management alerts to help avoid delays or inaccurate content posting to the registry.
