Pharmaceuticals

In a recent study it was found that the top of mind challenges that Bio/Pharma organizations are grappling with are the regulatory risks of post approval post market surveillance, privacy, assessing adverse drug reactions (ADR's) ie Pharmacovigilance, reduction of redundant regulatory efforts and compliance related training.

Other challenges faced today include:

• Product pipeline and increased competition
• Pricing - from generics to reimbursement and government intervention
• Adverse reaction/effects of drugs and management thereof
• Recruitment and retention of highly skilled resources
• Reputation risk
• R&D productivity and return on investment
• Increased regulatory pressures such as compliance, privacy and security 

It is in this environement that the risk and compliance officers need to operate effectively and efficiently.  The challenges posed lead the risk and compliance function to require solutions that will:

• Meet regulatory requirements within cost and time constraints
• Obtain a complete enterprise and accurate view of risk
• Reduce redundancy and duplication of information
• Obtain a single integrated view of risk and compliance across the organization
• Ongoing risk assessment and pharmacovigilence 
• Accurate modeling and management of projects
• Aggregating and normalizing disparate risk and compliance information from various geographies and business units
• Privacy surveys, audits and corrective action management

Cura's Enterprise GRC Platform has been developed to assist customers achieve their strategic objectives and maintain advantage in this highly regulated environment.  Cura's proven success in the sector includes customers such as Johnson & Johnson, GlaxoSmithKline, Eli Lilly, and Health Services Australia.

Cura will assist your organization in:

• ERM Best Practice - Easy to use risk management information system that deals with identification, analysis, ongoing management and treatment of risks, RCSA's, full alignment with ISO 31000, and integration with quantitative, project management.

• Advanced Reporting - covering reports and dashboards that range from local stakeholder related data right through to advanced aggregation, audit committee, risk committee and ultimately board reporting needs.

• Whistleblowing and Case Management - Capture of whistleblowing and complaints recording, case management features of Cura will assist in the achievement of a better governed organization through well documented investigations and audits.

• Centralized Information Store - Full content and document management so that policy, process, risks and controls can be displayed in configured views based on the role of the user and in the context that the user needs to make effective decisions.

• Corporate-wide Surveys - Unlimited surveys across the organization and its external supply chain/providers that facilitate accurate self assessment, regulatory compliance management, audits, and provide first-pass response results and corrective actions to reduce non compliance and breaches.   

Related Information: 

• Data Sheets
• Case Studies
• White Papers

To find out more about Cura's capabilities in this sector, please contact us .