Pharmaceutical & Biotech

Leading pharmaceutical and biotech companies are accelerating drug trials while improving compliance in a tightly regulated, global industry.

Challenges

Lack of agility, insight, and standardization leads to delays and risks

Today’s pharmaceutical and biotech companies grapple with complex drug trial processes, highly regulated promotional programs, and complex supply chains. At the heart of all these challenges are contracts.

Ultimately, pharmaceutical and biotech companies face broad 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 reduce profits due to sourcing inefficiencies.

  • Successful research and development are 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, and physician participation raises regulatory risk and impedes effective budget tracking

Featured Case Study

Sanofi selected the Icertis Contract Intelligence (ICI) platform as its contracting foundation.

With the Icertis Contract Intelligence (ICI) platform, leading pharmaceutical and biotech companies are accelerating drug trials while improving compliance in a tightly regulated, global industry.

The solution

Icertis Contract Intelligence

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.

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.

  • 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

  • Full Contract Lifecycle Management

    surrounding clinical trials, including site CDAs, Clinical Trial Agreements, budget sheets, site/CRO collaboration, budget consumption, and payment tracking

  • Sourcing Functionality

    including RFx management, events, bidding, evaluation, and awarding, as well as live auctions (including English, Dutch, FPSB, and SPSB)

  • Region-Specific Clause Management

    to ensure compliance in global operations

  • 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

Trusted by these companies

Next Steps

Explore Icertis Contract Intelligence

Icertis Contract Intelligence

Standardize, streamline, and automate every contract – everywhere

Transforming contracts into structured, connected, and on-demand data is just the beginning. Discover the power of intelligent contract creation, automation, and insights to realize the full intent and maximize the value of every contract, clause, and obligation across the enterprise.

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Clinical Trial Agreements and Budgeting application

Improve speed-to-market, compliance, and collaboration for new drugs

The Clinical Trial Agreements and Budgeting app allows pharmaceutical and life sciences customers to better manage the lifecycle of CTAs, CDAs, and ICFs while tracking trial budgets. The app enables deeper collaboration with CROs and Service Providers through an online portal, allowing easy management of all outsourced activity. Budget-tracking capabilities help capture and track budgets on studies and research and integrate with financials and CTMS solutions to drive visibility.

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Icertis Sourcing Application

Place contracts at the center of the sourcing process

Ensure compliance, minimize risk, and create long-term strategic agility while gaining full visibility into supplier’s risk profile and ensuring compliance throughout the procurement process. 

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Icertis Obligation Management

Manage commitments and realize the full value of entitlements

Transform how your organization identifies, creates, manages, and fulfills obligations previously hidden in complex contract language with Icertis Obligation Management.

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