Life Sciences & Research
Contract Research Organizations
Study systems and sponsor audit evidence for clinical, pre-clinical and specialist CROs.
A CRO is audited by every sponsor it signs, as well as by regulators. In a qualification audit the sponsor's QA team does not ask whether your systems are secure. It asks for the IT SOPs, the validation records for the EDC and statistical environment, the user access reviews and the security logs. A gap in that file can lose the study.
The other test is time. Sponsors measure a CRO by how fast sites activate and how soon the database locks. Moraph CRO Solutions builds and runs the systems behind both, from the bid defense to database lock and archiving, and keeps the evidence your sponsors ask for.
Evidence for sponsors and regulators
CROs keep overhead low to win bids, yet sponsors expect validated systems. We set up study, biostatistics and site environments with sponsor QA auditors and the FDA in mind, configured to support your 21 CFR Part 11, ICH GCP and GDPR obligations. Validation decisions and Part 11 compliance for your use stay with your QA team; we provide the documentation and test records.
Moraph products for CRO study work
Clinical Trial Patient Recruitment App: pre-screening, electronic consent, reminders and symptom reports for participants, with the source of each referral recorded. Signed consents can be filed to the eTMF, and designated data passed to the EDC. Site staff decide eligibility; the app does not.
Grant & Site Payment Manager: matches completed visits from the CTMS to each site contract and prepares payment requests and sponsor invoices for approval. Payments go through your accounts payable system; Moraph does not hold funds, and the product does not pay study participants.
Cloud Content: Box workspaces where medical writers and regulatory staff co-author submission documents with version control and audit logs. It is not a research data capture system.
We also administer Medidata Rave, Veeva Vault or Oracle Clinical, including study build and user provisioning after contract signature; run a statistical computing environment for SAS, R and Python; and integrate decentralized trial tools, such as wearable feeds and telemedicine, into your data management plan.
By function
Clinical Operations
For leaders of a traveling CRA workforce: secured laptops and tablets with offline access to the eTMF and monitoring plans, a portal where sites upload redacted source documents for remote source data verification, and a helpdesk for site staff with EDC login problems.
Data Management & Biostatistics
For data management heads measured on time to database lock: nightly edit checks and reconciliation that flag discrepancies; managed SFTP between labs, vendors and sponsors, with transfer specifications enforced and data encrypted in transit and at rest; and end-of-study archives in a readable format for the required retention period (often 25 years).
Regulatory & Safety
For safety and submission teams working to statutory deadlines: Argus or ArisG safety database hosting with high availability and disaster recovery, to support your 7-day and 15-day expedited reporting; and secured connections to the FDA Electronic Submissions Gateway (ESG) and the EMA eSubmission Gateway for eCTD submissions.
Support in sponsor audits
Audit support: we join you in sponsor audits and provide the IT SOPs, validation records and security logs auditors ask to see.
Tickets ranked by study date: our Global Resilience Operations teams move an issue that threatens a database lock date to the front of the queue.
Vendor qualification: niche vendors you bundle into bids, such as eCOA and IRT tools, are assessed against the standards your sponsors expect.
When a sponsor asks about Moraph as one of your vendors, point them to the Trust Center, where our SOC 2 Type II audit report and control mappings are available under NDA.
Solutions
Explore our Healthcare solutions
20 Moraph-built products and 20 managed platforms, each with its integrations and limitations listed.