Overcoming Today's Contracting Challenges with Technology in Pharma...
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Overcoming Today's Contracting Challenges with Technology in Pharma Sector

Pharma Tech Outlook | Saturday, March 14, 2020

A well-designed contract management solution guarantees optimum compliance and benefits the pharmaceutical industry.

FREMONT, CA: Compliance and regulation in the pharmaceutical industry are evolving and becoming more difficult due to globalization. This has a detrimental effect on an organization's contracts, which serve as the foundation for all business relationships. Contracts are critical in all transactions—whether they involve purchasing from suppliers, expediting drug trials, collaborating with healthcare experts or Contract Research Organizations (CROs) for clinical studies, or engaging with wholesalers and Pharmacy Benefit Managers on the sell-side. Contracts are a significant source of revenue, but poorly managed contracts can become the most crucial liability. Pharmaceutical companies require a technology solution to streamline their contracting process and increase operational efficiency to address the growing complications. Due to stringent regulations and increased contract risks, investing in advanced contract management systems is no longer a luxury but a requirement.

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Various departments such as manufacturing, marketing, research and development, management, and legal lack visibility into deadlines, reminders, contract expiration and renewal dates, and any other terms that must be closely monitored to ensure maximum contract compliance. This is mainly due to the absence of standardized processes and disparate systems throughout the enterprise, which results in delayed and substandard governance. Most critical information regarding the purchase price, volume, standard terms, and suppliers is lost in poorly managed contracts. For pharmaceutical or biotechnology companies, ongoing research and development are critical. However, controlling and budgeting for clinical trials for drugs are complicated because contract managers frequently lack the time or technological tools necessary to verify that contracting parties such as third-party drug manufacturers, suppliers, and researchers are complying with ever-changing global regulations, posing compliance issues for each state, jurisdiction, and country. Rigid processes and a lack of integration with business applications are significant factors preventing business growth teams from working faster and closing commercial deals, particularly in global regulatory compliance changes. Contract management software incorporated with other enterprise applications will assist in quickly monitoring and settling various pieces of information. A lack of automated tools frequently results in expiration dates being missed. Sending false documents for review or approval, signing false documents, or failing to secure all signatures are all examples of industry inefficiencies. Due to broken links, file renaming, or haphazard filing, contracts, and related documents are frequently lost. This can be attributed to traditional contract management's inefficient decentralized document storage method.

Pharma companies deal with hundreds of contracts, which make tracking them difficult. Even missing one deadline can result in significant financial loss. A custom AI tool can assist pharma companies in avoiding such unfavorable situations by setting reminders for expiration or renewal dates. Additionally, pre-defined milestones and metrics provide insight into contract performance. Before bringing new drugs to market, pharmaceutical companies must adhere to FDA regulations. Inadequate compliance results in unnecessarily long delays missed deadlines and financial losses. Automated contracting solutions analyze FDA compliance documents for accuracy and timely submission. Besides maintaining audit trails, they also tailor contracts to regional requirements, enhancing compliance. Centralization is the bedrock of the contract management process; without it, reporting and analysis become extremely unlikely. Contract repository software consolidates all contracts into a single secure, centralized repository.

Additionally, it enables the pharma companies to create a library of standard templates and clauses that can be used to ensure maximum compliance when writing a contract. By creating a centralized repository, contract lifecycle management (CLM) enables a team to access contracts and associated documents from any location securely. Pharma companies can restrict their team members' activity according to their preferences using the role-based permissions feature, including "read-only" and other customized access settings. Additionally, CLM automates and streamlines the entire contracting process, from contract requests to authoring and negotiation, execution, electronic signature, and obligation management. This saves time and ensures accuracy, as human error is eliminated. CLM enables pharma companies to gain complete visibility into their supplier relationships, including regulatory compliance and contracting risks. Additionally, this allows them to manage supplier relationships more effectively and mitigate regulatory risks.

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