Healthcare
Life Sciences & Research
We provide IT and data services to pharmaceutical companies, biotech startups, CROs and academic medical centers.
In regulated research the record is the evidence. An inspector asks who entered a value, when, under which version of the consent form, and whether anyone changed it afterwards. If the system cannot answer, the result can be a Form 483 observation or a rejected submission, whatever the science shows.
Moraph Life Sciences Solutions works with pharmaceutical companies, biotech startups, Contract Research Organizations (CROs) and academic medical centers. Their systems answer to FDA 21 CFR Part 11 for electronic records and signatures, EU GMP Annex 11 for computerized systems, ICH E6 Good Clinical Practice and, for personal data from the EU, GDPR. We build to ALCOA+ principles: data is attributable, legible, contemporaneous, original and accurate, and also complete, consistent, enduring and available.
Software for trial sites and sponsors
Clinical Trial Patient Recruitment App: a participant app for pre-screening, eConsent, visit reminders and symptom reporting, with a workspace for site staff. Consent is captured with the IRB-approved version, and signed records can be filed to your eTMF. It does not decide eligibility or whether a report is an adverse event, and it is not an EDC or a CTMS. Consent languages are added only as approved translations are supplied.
Grant & Site Payment Manager: matches completed visits and milestones from your CTMS to each study contract, prepares invoices and site payment requests for approval and reconciles payments received. Moraph does not hold funds, the product is not your general ledger, and it prepares, but does not submit, data for Open Payments or federal financial reports.
Cloud Content (Box for Healthcare): SOPs, protocols and submission documents shared with external partners under version control and audit logs. Box is a content platform, not a research data capture system, and we do not certify your compliance with 21 CFR Part 11.
We also deploy Snowflake or Databricks as a research data platform where clinical and real-world evidence data can be analyzed without leaving a controlled environment, and Zoom or Teams for remote trial visits.
By type of organization
Pharma & Biotech
Discovery partners should see only the molecules they are meant to see, so we build data clean rooms behind zero-trust network access. Cloud compute for genomic sequencing and molecular modeling scales up for a run and down when idle. After an acquisition, we move the acquired company's research data into your central data platform. More for pharma and biotech.
Contract Research Organizations
When you win a bid, infrastructure-as-code creates the SharePoint sites, data folders and access groups for the new study. Sponsor portals show enrollment and site performance in place of manual weekly reports, and a help desk for investigator sites helps coordinators get into the EDC system. More for CROs.
Academic Medical Centers & Institutes
Federally funded research may need NIST SP 800-171 controls, and physician-scientists need audited, IRB-approved routes to use clinical data for research under HIPAA and the Common Rule. Federated learning environments let universities train models together while patient data stays at each institution. More for academic centers.
Keeping validated systems in a validated state
A system validated on day 1 can fall out of its validated state after a vendor update on day 10. We run automated tests that check whether cloud updates have affected your GxP workflows, and scan for shared accounts and deleted audit logs, with alerts to your Quality Assurance team. Our service desk treats a site that cannot randomize a patient as a possible protocol deviation, not only a technical fault. Validation decisions and deviation assessments stay with your quality team; we supply the documentation and evidence.
For supplier qualification, quality and vendor-risk teams can obtain Moraph's SOC 2 Type II report and framework control mappings (GDPR among them) through the Trust Center, under NDA.
Solutions
Explore our Healthcare solutions
20 Moraph-built products and 20 managed platforms, each with its integrations and limitations listed.