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Prototype to Launch: A Digital Tool to Facilitate Phase 3 Clinical Trials

A rare genetic disease biopharmaceutical organization engaged Clarkston Consulting to help develop a digital strategy and a novel solution to support the company’s clinical and data operations needs due to its rapid scale-up. As the company prepared to ramp up Phase 2 and Phase 3 clinical trials, there was a clear need to move away from manual processes and Excel spreadsheets into a centralized platform that would facilitate the patient enrollment process and key interactions across physicians, primary investigators, and different functional owners within the organization.  

Historically, the client experienced inefficiencies as part of the patient referral process across different clinical trials. Specifically, many manual processes were involved, communication between functions was often redundant, and the organization lacked a single point of truth to orchestrate critical activities across clinical operations, medical liaisons, data operations, and area development managers. To solve this, Clarkston was brought in to help reinvent and reimagine what a potential new strategy and novel digital solution could do to streamline the patient referral process.  

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The journey started with a strategic “art of the possible” lens that required input from a variety of stakeholders, including clinical operations, research and development, regulatory and compliance, field teams, IT, data operations, major clinical research organizations (CROs), and IRT providers. From there, Clarkston developed digital prototypes to rapidly iterate on what a potential solution could look like and allow all involved parties to visualize and experience the new workflows in a tangible way.  

The project culminated with Clarkston supporting the development and creation of a web-based digital tool that streamlined workflows and helped this biopharmaceutical organization expedite patient enrollment. As a result, more than 10,000 eligible patients for this rare disease were screened by healthcare providers (HCPs) and principal investigators (PIs) across >40 sites in North America, resulting in the successful enrollment of patients across both Phase 2 and Phase 3 clinical trials.  

The tool has proven invaluable for our client, driving fundamentally new collaboration mechanisms across clinical operations, data operations, medical science liaisons (MSLs), and field operations, and providing a single source of truth that unifies internal and external stakeholders.  

Download the full Digital Tool to Facilitate Phase 3 Clinical Trails case study here, learn more about our Pharmaceutical Consulting Services by contacting us below. 

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Contributions from Vanessa Villalpando

Tags: Case Study, Commercial Launch