JVD Pharma Consulting, LLC

Representative Consulting Projects

Special short-term project to provide leadership during global strategic CRO-pharma partnership build following sudden termination of outsourcing Department Head
Assist executives with Due Diligence activities (reviewing clinical data, clinical trial conduct, regulatory risk, etc.) and advise on potential purchase(s) of pharmaceuticals and biologics
Complex clinical finance troubleshooting (projections, forecasting, cash flow, accruals, planning and cost-reduction strategies)
Established Joint Operating Committee and Executive Steering Committee, governance, third party vendor workstreams.
Contributed to MSA and rate card negotiations.
Facilitated tri-partite agreement with two global CRO preferred providers.
Middle interface between outsourcing and clinical operations, data sciences, medical affairs, pharmacovigilance groups.
Developed and implemented two new SOPs for clinical vendor selection and oversight.
Matrix and task management for department of 60+ outsourcing staff.
Clinical Operations leadership during M&A activities, due diligence, etc.
Building a clinical operations team after acquisition, training, ensuring smooth continuity of clinical trials

Clinical Development Operations leadership
Global study rescue - and ultimately finished enrollment early!
Early stage company clinical operations strategy planning and insights
Bridging gaps to keep programs moving while a search and hiring process is ongoing for permanent clin dev ops staff
Mentorship, training and guidance for newly promoted or hired clin dev ops staff
RFP Development and leading vendor selection efforts for CRO and other vendors for study(ies)
First In Human, SAD/MAD, Phase 1 study planning (including protocol design and operational execution)
Study management leadership and focused support
Focused efforts during study start up to ensure FPI
Protocol design, medical writing, designing plans and manuals and site materials
Site Visits (SIVs, IMVs, COVs, PSVs, recruitment booster visits, PI relationship visits)
Vendor set up, team interviewing, scope of work and specifications finalization
Vendor management and oversight visits
Close collaboration with QA on GCP topics/SOPs/CAPAs
Governance set up
CRO budget review and change order negotiation
Fixing CRO performance problems
RFPs for vendors, vendor selection, vendor negotiation and contracting
Data cleaning and review
Clinical Operations input into complex regulatory issues
Financial negotiations with CROs and vendors on an ongoing basis, and at closeout of study(ies) and program(s)
Other custom projects

Services