In the race to expand patient access and deliver novel treatments that save lives, executing clinical trial agreements (CTAs) should not be the stumbling block that slows the process and creates internal discord and misalignment.
Yet that is exactly what one multi-product biotechnology company experienced when the fast-growing global pharmaceutical pioneer began clinical trials for a break-through cancer treatment.
With trials set to roll out across EMEA, North America, and APAC, the biotech’s legal team faced burgeoning bottlenecks as the clinical team struggled to manage the scale, complexity and administrative burden associated with tens of thousands of multi-jurisdictional CTAs. Cue protracted negotiations, frequent escalations and costly delays to site start-up. Under pressure to meet tight trial timelines, the R&D team had to find a way to apply the same innovative spirit to internal process design as they were known for in drug development, if they were to succeed in getting life-saving cancer drugs to market quickly.
Super-charging contracting capabilities
Negotiating clinical trial agreements at scale requires access to specialized expertise, particularly when dealing with diverse geographies – talent that was in short supply within the company. Traditional law firms proved an expensive option that did not enable the close business alignment that their in-house legal team could bring. At this company, as with many clinical organizations, accountability for contracting was shared between the Clinical Operations organization and Legal, which managed escalations and the higher complexity work. However, the ClinOps team lacked the functional specialization to execute contracting at speed and scale – and Legal was capacity constrained to absorb the higher level of escalations and hand-offs.
Both organizations recognized that building an improved contracting “ecosystem”, with the skills, tools, processes and tech-enabled efficiencies was fast becoming a mission-critical requirement – yet the immediate need to get the work done made this near impossible.
Both the ClinOps and Legal team knew there must be a better way – and they found it in Factor. Bringing the immediate capacity and expertise to execute the trials at hand, in parallel, the Factor team worked closely with the in-house Legal and ClinOps organization with a Build / Operate / Transform approach to enable the biotech to build a scalable, repeatable, optimized contracting model supporting the company’s planned growth trajectory.
Transform while doing
Factor brought a cost-effective global team of contract negotiators with expertise in clinical research spanning 40+ countries to provide an immediate capacity lift to the in-house legal team. Meanwhile, the Factor team got to work developing the tooling and enablers including contract templates and interactive playbooks that would enable the client’s internal resources to execute the work in a phased manner. Leveraging the client’s contracting lifecycle management tool, the Factor team helped establish an improved data-focused approach to driving continuous improvements. One early revelation was that 80% of redlines were not in the client’s existing playbooks – prompting Factor to reinforce enabling artifacts.
Given the specialized expertise required for negotiating multi-jurisdictional Clinical Trial agreements, a key element in the transformation plan was to conduct a skills assessment of the in-house Contract Analyst team to identify training and development needs. As the necessary templates, playbooks and operating processes were created for in-scope jurisdictions, the Factor team conducted turnover training to the ClinOps team, enabling ongoing operations.
Accelerated clinical trial timelines
The results: The biotech saw fast impact with a 50% reduction in contracting cycle time, addressing revenue leaks associated with delayed site start-up, while building a clear roadmap for scalable contracting in the future.
The clinical team were empowered with effective process automation, driven by standard documentation, preset negotiation positions and escalation protocols.
And with reduced escalations and inbound handoffs from the ClinOps contracting analyst team, the in-house legal team found fresh capacity to guide the business as strategic enablers – just in time as the company announced its acquisition by one of the world’s premier biopharmaceutical companies.
In part through significantly reduced contracting cycle times – a reduction of up to 70% in some countries -- the partnership with Factor helped enable the biotech’s success in securing the approval of new indications in the immunology and oncology therapeutic areas.
A strategic enabler for acquisition
The biotech’s acquisition was premised on their ability to get new, innovative, and life-saving cancer drugs to market quickly. Factor’s work in negotiating CTAs was a foundational enabler of the acquisition, demonstrating the biotech’s ability to perform and conclude later stage clinical trials with a mature and scaled contracting program.
This transformation not only facilitated this biotech’s ambitious R&D goals but also solidified their position as a leader in innovative cancer treatments, ready to meet the demands of the company’s pending acquisition and beyond.
Discover more about how Factor's Integrated Law™ solution for clinical trial agreements can accelerate the process from lab to approval to market.
