In an environment with increasing clinical complexity, and decreasing clinical budgets, Scimitar helps clients stabilize and optimize their clinical operations to face the challenges of today’s shifting regulatory landscape. We helps clients evaluate process improvements within and across clinical support functions to maximize efficiencies and enable better resource utilization across a clinical program. Scimitar also helps the clinical support functions evaluate how they organize to support clinical trials and bring industry best practices in structuring their functional clinical support teams.
The need to manage increasing clinical complexity has become the cornerstone for most biopharmaceutical companies to manage their increased clinical productivity targets. The following challenges impede most clinical activities:
- Clinical Trial Costs – As clinical study complexity rises with increased multi-center sites, more targeted enrollment populations and greater efficacy requirements, the costs of trials have sky rocketed to $300 - $600M for Phase III studies.
- Globalization – There is an increasing trend of conducting more clinical studies outside of the United States to complete the study to increase enrollment and drive down external costs. While this can be seen as a positive, it also drives the complexity of clinical studies and requires more coordination between the various clinical study teams.
- Regulatory Compliance – The need to manage a clinical program across many sites and potentially many countries also brings the need to manage multiple regulatory requirements. Many companies utilize a hub or affiliate approach to manage the regulatory requirements and compliance for a given country, but still lack the necessary integration, oversight, and coordination to manage regulatory compliance effectively.
- Clinical Data Management – Clinical data is seen as a key corporate asset, and the effective use of clinical data capture systems allows for the quick review and decision-making against clinical data. Being able to sustain an integrated database for product registration requires a long-term process and investment to maximize the return for organizations.
- Outsourcing – Many companies have started utilizing preferred clinical research organization (CRO) partners or functional services providers to help manage their clinical studies, moving their cost model from fixed to variable expenses. However, with an improper oversight model, the cost savings are greatly outweighed by the need to redo any of the work.
Scimitar partners with our clients to help them realize the full value of their clinical operations. Our methodology helps our clients think through:
Example Engagement #1:
Top-5 Pharmaceutical Company: Accelerating Study Start-up
Situation: A major pharmaceutical company was looking to cut its study start-up time from protocol approval to first patient in by 50%
Approach & Outcomes
- Scimitar brought together a cross-functional across all aspects of clinical operations, including drug supply, to identify pain points and prioritize solutions that would have the biggest impact in reducing the study start-up cycle times.
- Through this process, 5 core pain points were targeted and addressed which included addressing breakdowns in communication between clinical and supply, establishing a key country list to accelerate internal approvals, and improving site selection methodologies.
- Pilot studies for the program had a reduced study start-up cycle times by an average of 60%.
Example Engagement #2:
A Top 5 Biotech: Addressing Major Interaction Challenges with Trial Sites
Situation: Our client faced major challenges in effectively managing the relationships of hundreds of global clinical sites, where investigator and trial coordinator relationships were strained.
Approach & Outcomes
In this initiative we helped to identify and solve for these major pain points sites and investigators experienced across the study lifecycle, spanning from site identification and selection to ongoing relationship management. Scimitar proceeded with an innovative 'interaction-centric' approach, that entailed...
- Conducting detailed workshops to map out key interactions, and highlight 12 major challenges.
- Verifying and prioritizing these challenges during multiple interactions with physician and site contacts.
- Identifying the appropriate solution principles that needed to be addressed, and where the client skills needed to be 'up-leveled'.
- Capturing and implementing nine highly targeted solutions. These detailed solutions were then implemented globally with solution owners, implementation plans and metrics of success. Ultimately, rollout has had a demonstrable, quantified impact on all challenge areas that were identified.