Contract Management Challenges for Pharmaceutical and Biotech Companies
Today’s pharmaceutical and biotech companies are grappling with complex drug trial processes, highly regulated promotional programs, and complex supply chains. At the heart of all these challenges are contracts.
In working with some of the world’s largest pharmaceutical and biotech companies, Icertis has identified a number of common contracting challenges:
- Successful research and development is critical for success, but managing and budgeting for clinical trials is complicated by complex regulations and specialized contracting requirements
- Global operations present compliance challenges as each jurisdiction has its own rules and regulations around drug development and sales
- Non-standardized processes and disconnected systems reduce visibility across the enterprise, impeding governance and compliance: purchase price variance, projected vs. actual volumes, standardized terms, rationalized suppliers, etc.
- A lack of agility in sales programs makes it difficult to respond to changing regulatory or commercial requirements
- Lack of integration with other enterprise processes impedes tracking of rebate/claim settlement in channels and budget/Fair Market Value tracking in trials
- Lack of insight into contracts with external experts for speaking events, webinars, research collaboration, physician participation raises regulatory risk and impedes effective budget tracking
Ultimately, we find that pharmaceutical and biotech companies face a broad set of contract challenges that span R&D, sourcing, sales and promotions. If left unaddressed, these challenges can lead to serious delays in bringing a drug to market, raise the risk of major fines for non-compliance, and reduced profits due to sourcing inefficiencies.
Icertis Solutions for Pharma and Biotech
Icertis has implemented Contract Lifecycle Management (CLM) solutions for more than a dozen pharmaceutical and biotech companies, including five of the top seven in the world.
While the ICM solution is ultimately configured for each customer, our CLM for pharmaceutical and biotech capabilities include:
- Buy-side contracting functionality including direct and indirect procurement contract management, integration with enterprise P2P systems, and the ability to track price and volume variance across the supply chain
- Region-specific clause management to ensure compliance in global operations
- Sourcing functionality including RFx management, events, bidding, evaluation and awarding, as well as live auctions (including English, Dutch, FPSB and SPSB)
- Full contract lifecycle management surrounding clinical trials including site CDAs, Clinical Trial Agreements, budget sheets, site/CRO collaboration, budget consumption, and payment tracking
- External expert contracting, event contracting, and tracking of compliance and payment
- Promotion and rebate capabilities including full management and tracking of license agreements with tiered royalty structures based on country-specific sales and rebate agreements with distributors and pharmacy benefit managers
Icertis’ pharmaceutical and biotech solutions offer unmatched benefits across the entire enterprise. We handle all contract types, have integration adapters for other enterprise systems, and can ensure that companies continue to maximize the value of their contracts long after each one is signed.
Learn More from the Industry Experts
Featured Solutions for Managing Pharmaceutical and Biotech Contracts
Within the ICM product portfolio, these solutions enable healthcare companies to drive even more value from their contracts.
ICM Clinical Trial Agreement and Budgeting app
Better manage the lifecycle of CTAs, CDAs and ICFs while tracking trial budgets.
Place contracts at the center of the sourcing process to ensure compliance, minimize risk, and create long term strategic agility.
ICM Obligations Management app
Significantly reduce risk by improving visibility into, and compliance with, all obligations and commitments.