Life Sciences & Research
Pharma & Biotech
IT, data and validation for biopharmaceutical and gene therapy companies, from discovery to launch.
In a regulated life sciences company, a system is only useful if its records will stand up in an inspection. An FDA, EMA or PMDA inspector asks who created a record, when, what changed and whether the system was validated for that use. If a cloud platform updates itself and nobody re-tests the GxP workflow, the system is out of its validated state, which can lead to a Form 483 observation and questions about a submission.
Moraph Pharma Solutions works with biotech startups with one molecule and with large pharma companies running global supply chains. Most of what we do is keeping systems in a validated state as they change, while research teams keep using open science and AI tools.
What a validated build includes
Our builds follow ALCOA+ data integrity principles and include Computer System Validation (CSV) documentation, electronic signatures configured to support 21 CFR Part 11, and Zero Trust segmentation to protect intellectual property from espionage and ransomware.
Validation and Part 11 compliance for your intended use remain your QA team's decisions. We provide the documentation and test evidence; we do not certify your compliance.
Moraph products for pharma and biotech
Clinical Trial Patient Recruitment App: a participant app for pre-screening, electronic consent with the IRB-approved version, visit reminders and symptom reports, plus a workspace for site staff. It can run in a single-tenant environment for a sponsor. It does not decide eligibility or classify adverse events, and it is not an EDC or CTMS; it connects to yours.
Cloud Content: Box for regulated document work with external CROs, with version control, audit logging, classification and retention configured by Moraph. Box is a content platform, not a research data capture system, and some features depend on the add-ons you license.
Grant & Site Payment Manager: tracks study budgets and the visits and milestones that earn site payments, and prepares payment requests for your accounts payable system. For research payments to sites, it prepares data your team uses for Open Payments (Sunshine Act) reporting to CMS; it does not submit those reports, and Moraph does not hold funds.
We also run partner platforms: AWS or Azure burst capacity for genomic sequencing, molecular dynamics and in silico modeling; and a Snowflake or Databricks data lakehouse that combines lab instrument, clinical trial and real-world evidence data for analysis.
By function
Research & Discovery
For R&D heads who need to share data without losing control of it: research enclaves for sharing specific datasets with academic partners or AI vendors while blocking exfiltration of core IP; secure links from sequencers, mass spectrometers and bioreactors to the cloud in place of USB drives; and a managed MLOps pipeline that keeps candidate-selection models versioned and reproducible.
Clinical Operations
For teams starting global trials: security for the apps and wearables that collect endpoints at home in decentralized trials; eTMF infrastructure that keeps inspection documents indexed, searchable and protected from alteration; and help for investigator sites with EDC access, so data entry backlogs do not delay database lock.
Commercial & Medical Affairs
For launch, market access and field teams: Veeva or Salesforce CRM with offline access to approved content; security for the nurse call centers and hubs that run patient support programs; and digital asset management so only content approved by Medical-Legal-Regulatory (MLR) review reaches the field.
Keeping systems in their validated state
Our managed service for GxP systems includes:
Continuous validation: automated testing after each cloud update to confirm GxP workflows still behave as validated, following the risk-based approach in the FDA's Computer Software Assurance (CSA) guidance.
Escalation by consequence: our Global Resilience Operations teams escalate time-critical events, such as a freezer alarm in a biobank, immediately.
Data integrity monitoring: shared passwords, deleted audit logs and orphaned data are detected and reported to your QA team.
Your QA and security reviewers can examine our SOC 2 Type II report, security policies and penetration test summaries; the Trust Center provides them on request, subject to an NDA.
Solutions
Explore our Healthcare solutions
20 Moraph-built products and 20 managed platforms, each with its integrations and limitations listed.