Situation: Sponsor nearly 100% outsourced. Client frustrated with change orders, CRO personnel turnover, lack of visibility into CRO-driven site management.

W&A Solution: Taught principles of customer control. Ran role-playing workshops with staff having primary CRO interface responsibilities. Developed new VOM processes and re-wrote SOPs. Altered use of internal and CRO software to provide real-time tracking of site compliance. Mentored primary interface staff with pre- and post-meeting debriefings.

Situation: Sponsor Pharmacovigilance department with three European and two US locations, all derived from acquisitions, following diverse case processing and intra-company communications methods. Client worried about compliance, completeness and efficiency.

W&A Solution: After interviews at each location, identified potential change agents and provided neutral and PV-informed facilitation of a series of workshops that confronted and resolved inter-site differences, using W&A methods which neutralize conflict and ensure eventual consensus. Legitimate local differences were identified and codified.

Situation: Large pharma sponsor was a long-time user of EDC and was simultaneously using multiple software vendors both within and between sponsor sites. The client recognized the high dollar cost and resource inefficiency, while wanting to expand EDC use and benefits.

W&A Solution: Using our decades of experience with a broad of vendors and understanding the impact of the maturity of their offerings, W&A facilitated a methodical yet accelerated global consensus on vendor selection, without using artificial numeric measures for differentiation. During the selection process, an as-is process assessment led to a smooth adoption of W&A’s milestone meeting method for study startup, and adoption of an IDRP approach to improve efficiency. W&A trained internal specialists in the new processes and mentored their progress.

Situation: Having implemented EDC widely, the sponsor was disappointed in the breakdown in the new study startup process, the frequent “heroics” required to complete programming on time, and the adverse impact on study team and biometrics employee satisfaction.

W&A Solution: Showed client how, in a practical and low-resource manner, to collect and analyze a small set of relevant metrics about current performance. Interviews established a baseline for job satisfaction. Process workshops showed the staff the interrelationships between tasks, and the follow-on consequences of poor implementation of the intended processes. Both the metrics and the workshops produced convincing and measureable targets for improvement which allowed for employee buy-in and demonstrable progress.

Situation: Client faced compliance violations from CROs failing to provide timely accounting of site documentation. Other reporting delays were interfering with trial management. Assumed solution was to install a complex CTMS at high cost and requiring too much staff and calendar time.

W&A Solution: Proposed client focus on near-term solution that could be expanded over time to incorporate less-urgent functionality. Facilitated analysis of software platform choices and consequent vendors. Managed configuration of selected tool and subsequent change management required for multi-site, multi-department acceptance of new tool, which was delivered in practical stages.

Situation: Sponsor running a very large global studies with thousands of patients and hundreds of sites. Substantial problems between the CRO, in-house data management, and academic advisors caused by poor communication and trust, under-utilization of the EDC software, and disagreements on process and performance.

W&A Solution: We provided a layer of data management expertise and executive perspective above the conflicting parties, acting to facilitate the sponsor’s re-assertion of control of the study, considerably improve the use of the software and subsequent processing times, and mentor in-house data management in using streamlined processes. This resulted in greatly improving overall operational performance and contributed to a successful pivotal trial.

Situation: Biotechnology company was growing quickly, recognized clinical development-related software purchases were uncoordinated, with little or no consideration of data integration, platform compatibility, or efficiency.

W&A Solution: We aligned key business drivers, management appetite for risk, projected growth patterns, and technology developments to create a “road map” from the status quo to a five-year desired state, based on a broad consideration of operational priorities, likelihood of risk, particular company interdepartmental relationships, and available resources.

Situation: Sponsor was experiencing delays in study startup due to using different IxRS vendors in each trial, depending on CRO used and therapeutic area. Client wanted streamlined process for IxRS study definition and cross-study consistency.

W&A Solution: Developed and delivered standardized and streamlined approach to IxRS study specifications independent of vendor, with flexibility to be used across the pharma enterprise. Developed business model for subsequent vendor contracting. Taught and mentored study teams in the new process and followed through with change management assistance.