Preclinical
Build the Financial and Operational Backbone.
Financials and procurement, lab supply purchasing, clinical trial planning and budgeting, R&D time capture, license and royalty management, and multi-currency from the start.
27
Oracle Cloud ERP Deployments for Pre-Commercial Companies
50+
Life Sciences Deployments in All
21 CRF
Validated to 21 CFR Part 11 and EU Annex 11
We Know How a Drug Company Actually Runs
Your product is made at a CMO. Your lots move through partners you don’t control. Your finance team has expensed R&D for years, and at launch has to capitalize inventory, book gross-to-net, and report Sunshine Act spend, all while auditors and regulators watch.
We speak that language, from chain of identity in cell therapy to lot genealogy across contract manufacturers. You spend your time deciding, not explaining. And when there’s a choice to make, we’ll lay out the options and tell you which one we’d pick, and why.
“Apps gave us options our prior implementation partner never even mentioned. And they weren’t just talking. They showed us how it would work in the configuration.”
Life Sciences CIO
Quality Built in at Every Stage
Start with what you need now, on a foundation built for what comes next. And when a new indication sends you back into trials, we’ve been there too. Deviations, nonconformance, complaints, and CAPA tracked from clinical through commercial. Validated on day one, and every release after.
Everything You Need, End to End
One partner across finance, supply chain, commercial, people, and validation, so every stage of the roadmap runs on one connected Oracle system.
From preclinical budgets to public-company reporting: clinical trial costing, royalties, gross-to-net and ASC 606, multi-entity close, FX, and statutory reporting on Oracle ERP Cloud Financials.
Expanding your Life Science Company Globally?
Scale Your ERP Solution to Meet The Needs of a Public Company
Clinical Trials Planning and Reporting for Oracle Cloud Financials
Run a supply network you don’t own: CMO and CDMO models, lot traceability across partners, clinical and commercial supply planning, 3PL integration, DSCSA, and quality from deviation to CAPA.
Biotech Manufacturing Software
Gene Therapy Customer Story
Pharma Migration Case Study
Be ready to sell before launch day: order-to-cash, chargebacks and rebates, Sunshine Act reporting, and analytics that show what’s working across new products and markets.
Sunshine Act Reporting Data Sheet
Royalty Management Data Sheet
See what’s next before you get there. Roadmaps for commercial readiness, supply chain strategy, and modernization, with clear options and a recommendation, drawn from 50+ life sciences deployments.
SCM Road Map and Strategy Data Sheet
EBS Future-state Workshop
Hire, train, and keep the people a growing company runs on, with Oracle HCM Cloud and GxP compliance training tracked in one place.
How Oracle HCM Cloud Can Empower Your Life Science Workforce
Modernizing and Automating Aging Systems with Oracle HCM
Growth Customer Story
Risk-based validation to Part 11, Annex 11, and GAMP 5, aligned to FDA CSA guidance, with release management that keeps you validated through every quarterly Oracle update.
FDA Guidance Blog
GxP Release Management Data Sheet
Cloud Validation Blog
Validated on Day One, and Every Release After
We validate as we build, using a GAMP 5 risk-based approach aligned to FDA Computer Software Assurance guidance and Oracle’s validation methodology. Your system meets 21 CFR Part 11, EU Annex 11, and SOX, and you get the full document set: validation plan, test plan, traceability matrix, process qualification, and validation summary.
Then our managed services team keeps you validated through every quarterly Oracle release, with release-note monitoring, regression testing, and release management. It’s been built into how we deliver for more than ten years.
A Small Sample of Our Life Sciences Customers
Case Studies
Transforming Clinical Trial Solutions with Oracle Cloud
An Arizona-based health clinic chain proudly operates ten Community Health Centers across the region, along with various state and federal health programs. With a commitment to providing affordable primary care, the organization is dedicated to sustaining and improving community health through accessible medical services
Apps Associates Helps Cell Therapy company Intra Cellular scale Financial & Supply Chain platform
Intra-Cellular Therapies was in the process of undergoing a massive period of growth, as they prepared for new drug product launches. With the aggressive ramp-up of company activity, the company decision makers soon found that the manual nature of their financial processes was a pain point. There was an evolving need for a more sophisticated…
Apps Associates Helps REGENXBIO Tackle a Double Migration – Starting with Oracle EPM Cloud
REGENXBIO runs finance and planning on Oracle ERP and EPM Cloud, implemented by Apps. When it was time to think about going commercial, our team sat down with theirs to map what the business, and its systems, would need next.
Our Experts
John Schmottlach
Chief Strategy Officer
Leads advisory, helping life sciences companies plan their next stage on Oracle.
Jaret Balter
VP, Application Delivery
Has guided biotechs from their first ERP through commercial launch, from CMO models to gross-to-net.
