Services
Relevant CDMS Expertise
Medidata Rave, Medrio, Veeva, Merative Zelta, Inform, Castor
Vendor Expertise
Contract Research Organizations, Clinical Data Management Systems, ePRO, eConsent, Safety Lab, Specialty Labs, Biostatistical providers, etc.
Vendor Selection and Budget Negotiation
Provide vendor recommendations and references to the Sponsor team. Review and feedback on feedback on RFIs, RFPs and budget content. Contribute to the “narrowing down” of vendors and participation in bid defenses. Expertise in budget negotiations, with the goal of reducing numerous downstream change orders while ensuring the needs of the study are met.
Vendor Implementation & Oversight
Manage and oversee DM-related deliverables, ensuring that each vendor is executing their responsibilities in accordance with the budget and contract in place. Assist in the justification and adjudication of applicable change orders. Oversight includes the coordination of timely deliverables, timeline management, collaborative communication, issue identification and resolution, etc.
SOP Development
Develop a SOP implementation plan that properly validates the business operations. Identify key stakeholders and establish achievable timelines for completion. Define the full SOP package including the SOP and all associated work instruction(s), form(s) and template(s). Proficient in the authoring, review, formatting and/or finalization of controlled documentation in accordance with the implementation plan and scope.
Full-Scope Data Management Representation
Join the Sponsor study team as their internal Data Management representative to the external study team. Primary responsibilities include guiding the internal team on all data management-related matters, reviewing all associated documents, and overseeing the external data management team ensuring quality and compliance to industry regulations and best practices. Functions as a dedicated X% FTE, with the resourcing flexibility of a consultant.
Process Auditing & Improvement
Align with department and/or company leadership on the specific data management processes and procedures that need auditing and/or improvement. Scope may include the expert review of active documentation (SOPs, WIs, How-tos, etc.), executive summary of findings and related recommendations for improvement, collaboration with key department members on improvement goals, generation of an improvement strategy/plan, associated timelines for improvement, coordination of improvement efforts, etc. Proficient in the authoring, review, formatting and/or finalization of controlled documentation