- 15 min read
- DEVINDERJEET SINGH
Introduction
First, let’s take a moment to acknowledge the fact that the last three years have been a momentous time for the life sciences domain. In stating that, we shouldn’t limit the benchmark of successful drug R&D to just the COVID-19 vaccines. In 2021, a ground-breaking vaccine for malaria received endorsement from the World Health Organization and we also saw promising late-stage clinical trial results for an HIV vaccine. Some might argue that we are on the verge of entering a new golden age of medical sciences and pharmaceutical companies are leading the way.
Be it for a vaccine or a new OTC drug, clinical trials play a pivotal role in the lifecycle of any novel pharmaceutical or medical product. Trial outcomes are what ultimately dictate if a product will receive the necessary regulatory approval on time to go to market. It also offers the necessary data-led evidence a pharma business will need to justify the cost of R&D to shareholders, improve market position, and continue investing in further drug development.
Outsourcing to Manage the Inherent Complexity of Clinical Trials
Clinical trials are inherently complex and expensive undertakings. According to researchers at Tufts University’s Center for the Study of Drug Development, there has been a hefty increase in the total number of procedures across trial phases; a 69% growth in Phase II and a 49% growth in Phase III. In turn, it has contributed to increasing an average trial’s cost per volunteer and significantly reducing patient retention rates.
As a result, pharma companies have come to rely heavily on outsourcing through clinical research organizations (CROs) to meet efficiency and budget objectives. CROs offer pharma companies the requisite operational expertise, geographic reach, and robust infrastructure to help the company conserve its own limited resources for more strategic activities. Outsourcing to CROs has also helped lower the entry barrier into the pharmaceutical space by allowing small and medium businesses to conduct clinical trials in areas where they may not have the expertise and resources to independently drive product development.
Of course, contracts between pharma companies and outsourcing providers such as CROs, are a critical lever of success when it comes to ensuring better clinical trial outcomes. Why? The simple answer is that budget and contract negotiation are the biggest causes for delays in clinical trials.
Legacy Contracting is a Key Bottleneck
Broadly speaking, the underlying legal paperwork for a clinical trial will typically comprise supplier contracts, NDAs, waivers, patient agreements, site agreements, and so on. Each of these contracts will need to be authored by a pharma company and its CRO partner and then negotiated with several third parties such as hospitals, patients, research investigators, and volunteers.
If the entire process – from draft to signature – is driven manually, the three immediate problem areas that make themselves apparent are: scalability, risk, and cost-efficiency. Typically, legal teams are tasked with assembling first drafts using legacy tools and without any insights into the enterprise’s contracting history, past performance data, and possible risk elements. Once a draft is ready, it is handed over to a third party, which then engages in a lengthy exchange over email to negotiate terms. Without a strong version control mechanism and a standard contracting playbook in place, the final draft could still contain deviations from the organization’s preferred position, missing clauses, and other such issues. Without a contract workflow and clearly defined processes, key stakeholders lack the visibility to review critical obligations and compliance conditions. In turn, it could expose the enterprise to risks, regulatory issues, budget overruns, poor delivery, and several other roadblocks.
Rewriting the Pharmaceutical Contract Managemement Playbook
At Sirion, we believe that the discovery of the next lifesaving blockbuster drug or vaccine shouldn’t be bottlenecked by contracting inefficiencies. Keeping this in mind, our flagship contracting platform – Sirion – has been designed from the ground up to heavily automate enterprise contracting and leverage intelligence from past contracting data to lower risk, secure better outcomes, and most importantly, reduce the cost associated with contracting and negotiation delays.
With Sirion’s pre-approved clause and template libraries and self-service contracting capabilities, pharma businesses, as well as CROs, can create contract drafts in minutes using standardized language to ensure that compliance requirements are met, aligning to the company standard position. Sirion’s AI-led legal review feature minimizes risky or missed clauses. Armed with a document assembly wizard and pre-built templates, Sirion ensures that contract authoring is done within minutes with a few clicks. Plus, companies can get AI-led prescriptive insights on language selection to reduce risks. To close the loop, the configurable workflow with e-signature tool integration helps to simplify approval and execution.
In addition to faster contracting, Sirion’s AI can also be leveraged to increase legacy and third-party contract extraction and digitization speed by up to 80%, improve contractual obligation compliance, reduce contract governance cost by up to 60%, and even help prevent value leakage to the tune of 6-12% at the invoice level. If you’d like to learn more about Sirion CLM, please reach out.
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