Solutions for Pharmaceuticals
Pharma companies manage long-cycle R&D programs with strict FDA compliance requirements. Clinical trial costs, regulatory submissions, and portfolio decisions are high-stakes and time-sensitive.
Common Challenges in Pharmaceuticals
These are the problems we hear most from Pharmaceuticals organizations. Our solutions are built to address them directly.
Clinical trial cost tracking is fragmented
Trial costs span CROs, internal labor, materials, and site fees. Tracking actuals against budgets across all sources requires manual consolidation.
FDA compliance workflows are paper-heavy
Regulatory submissions, audit trails, and compliance documentation are managed through manual processes and legacy systems.
R&D portfolio decisions lack real-time data
Go/no-go decisions on pipeline compounds are made with lagging financial and performance data. Portfolio views are assembled manually.
Regulatory submission management is slow
Preparing and tracking submissions across regions and regulatory bodies requires coordination across teams with no unified system.
Cost capitalization for R&D is complex
Determining which R&D costs should be capitalized vs. expensed requires judgment and data that lives in multiple systems.
Relevant Solutions from the Lab
Tessaract XPM
Portfolio management and cross-functional planning for R&D programs.
Material Management & Costing
Material cost tracking and procurement forecasting for clinical supply chains.
Proposal to Cash & CLM
Contract lifecycle management for CRO agreements and vendor contracts.
Common Questions
- Do you support FDA 21 CFR Part 11 compliance?
- Our solutions can be configured to support audit trail and electronic signature requirements for regulated environments.
- Can you integrate with clinical trial management systems?
- Yes. We build integrations with CTMS, ERP, and other platforms as part of the solution delivery.