Contract Research Organizations
Powering the Engine of Discovery.
Execution for the Global Study.
The Contract Research Organization is the operating system of modern drug development. You are the engine that turns a scientific hypothesis into a regulatory submission. In this sector, your product is speed. Sponsors hire you because they need to move faster than they can internally. Yet, this speed cannot come at the cost of quality. You are audited not just by regulators, but by every single client you sign. The mandate is unforgiving. You must spin up global trials in weeks, monitor thousands of sites, and deliver pristine data databases, all while maintaining thin margins and fighting for the next bid.
​
Moraph CRO Solutions is the specialized practice engineered to serve Clinical, Pre-Clinical, and Specialist CROs. We act as the secure bridge between the urgency of the bid and the reality of execution. From the proposal defense to the database lock, we provide the digital infrastructure that makes your delivery undeniable.
The Architecture of Value
Bid-Ready Velocity. Audit-Ready Integrity.
CRO executives face a relentless paradox. You must keep overhead low to win competitive bids, but you must possess enterprise-grade infrastructure to pass sponsor qualification audits. Moraph resolves this tension.
​
We operate on a philosophy of Scalability and Stewardship. Whether we are automating your site feasibility process or securing your biostatistics environment, our approach is rooted in "Audit-Proof" design. We recognize that in the CRO world, your technology stack is often the deciding factor in winning a study.
​
Our solutions are engineered to withstand the rigorous scrutiny of Pharma QA auditors and the FDA. We do not retroactively apply controls. We embed 21 CFR Part 11, ICH-GCP guidelines, and GDPR privacy safeguards directly into the architecture of your operations.
Our Operational Model: The Hybrid Advantage
Proprietary Precision Meets Best-of-Breed Scale.
CRO IT is often a struggle between billable project work and internal infrastructure investment. Moraph offers a unique hybrid capability that unifies the clinical service stack. We operate through two powerful, integrated streams:
1. Moraph Proprietary SaaS
Purpose-built applications for the industry’s most critical efficiency gaps. For the specific site management and reporting hurdles that generic software cannot handle, we deploy our own engineering. These are high-velocity applications designed to protect your margins.
-
Sponsor Transparency Portal: A real-time dashboard for your clients. It aggregates enrollment metrics, site activation status, and query rates into a branded view. It replaces the manual weekly status report, giving sponsors the "control tower" visibility they demand.
-
CRA Trip Report Accelerator: An automated workflow engine for monitors. It streamlines the creation and approval of monitoring visit reports. It utilizes voice-to-text and pre-populated data fields to reduce the administrative burden on your traveling CRAs.
-
Site Feasibility & Selection Hub: A data-driven site engine. It utilizes historical performance data to identify the best investigator sites for a specific protocol. It helps you promise realistic enrollment targets during the bid defense.
2. The Partner Ecosystem (CRO Edition)
Managed implementation and governance of global platforms. CROs need the power of modern eClinical and collaboration tools, but they need them validated and cost-effective. We are the experts in the "CRO Editions" of these platforms.
-
eClinical Suite Management: Administration of Medidata Rave, Veeva Vault, or Oracle Clinical. We manage the study build and user provisioning process. We ensure that new study environments are spun up instantly upon contract signature.
-
Biometrics & SAS Infrastructure: Management of the statistical computing environment (SCE). We architect secure, high-performance servers for SAS, R, and Python. We ensure that your biostatisticians have the compute power to run complex analyses without crashing the server.
-
Virtual Trial Platforms: Implementation of Decentralized Clinical Trial (DCT) tools. We integrate wearable data feeds and telemedicine platforms into your central data management plan, allowing you to offer hybrid trial capabilities to sponsors.
Clinical Operations
The Boots on the Ground.
For Clinical Ops leaders, the challenge is managing a remote, traveling workforce. Moraph provides the connectivity that keeps Clinical Research Associates (CRAs) productive on the road.
-
Mobile Monitor Enablement: We secure the laptops and tablets of your field monitors. We ensure they have offline access to the Electronic Trial Master File (eTMF) and monitoring plans, allowing them to work effectively in hospital basements with poor Wi-Fi.
-
Remote Source Data Verification (rSDV): We build the secure infrastructure for remote monitoring. We enable sites to upload redacted source documents to a secure portal, allowing your CRAs to verify data without getting on a plane.
-
Global Site Helpdesk: We provide 24/7 technical support for your investigator sites. We handle the password resets and EDC login issues for nurses and coordinators globally, ensuring that data entry never stops because of a tech issue.
Data Management & Biostatistics
The Product is Data.
For Data Management heads, the timeline to Database Lock (DBL) is the critical metric. Moraph ensures that the systems cleaning and analyzing the data are robust.
-
Automated Data Cleaning: We implement tools that run nightly edit checks and reconciliation logic. We identify data discrepancies automatically, allowing Data Managers to focus on complex queries rather than manual review.
-
Secure File Transfer (SFTP): We manage the movement of massive datasets between labs, vendors, and sponsors. We ensure that transfer specs are enforced and that data is encrypted in transit and at rest.
-
Archive & Decommissioning: We manage the end-of-study lifecycle. We ensure that study data is archived in a compliant, readable format for the required retention period (often 25 years), protecting you from future audit findings.
Regulatory & Safety (PV)
Vigilance is Mandatory.
For Pharmacovigilance teams, reporting timelines are statutory. Moraph ensures that your safety database is always available to receive and process adverse events.
-
Safety Database Hosting: We manage the infrastructure for Argus or ArisG. We ensure high availability and disaster recovery for these critical systems, guaranteeing you can meet the 7-day or 15-day reporting windows.
-
Regulatory Submission Gateways: We secure the ESG (Electronic Submission Gateway) connections to the FDA and EMA. We ensure that your eCTD (electronic Common Technical Document) submissions are transmitted securely and acknowledged instantly.
-
Dossier Collaboration: We provide secure workspaces for writing regulatory documents. We allow medical writers and regulatory affairs experts to co-author massive submission files without version control conflicts.
The Moraph Difference: Managed Governance
We Don't Just Host. We Defend.
The greatest risk to a CRO is the "Sponsor Audit." If a major pharma client audits your IT systems and finds a gap in validation, you lose the contract. Moraph distinguishes itself through our Managed Governance model. We act as the digital quality shield for your organization.
-
Audit Defense Support: We sit in the room with you during sponsor audits. We provide the IT SOPs, validation certificates, and security logs that prove your infrastructure is compliant. We turn IT from a liability into a selling point.
-
The "Study-Aware" Service Desk: For our CRO clients, support isn't routed to a generic queue. It is handled by our Global Resilience Command. We understand that a "Database Lock" deadline is a revenue event. We prioritize tickets based on study timelines.
-
Vendor Qualification: We manage the qualification of your niche technology vendors (eCOA, IRT). We ensure that the third-party tools you bundle into your bid meet the rigorous standards your sponsors expect.
Partner with Moraph
The Study is Yours. The Technology is Ours.
CRO leaders today are asked to do the impossible. Run faster, cheaper, and safer than the pharma companies themselves. You cannot navigate this competitive landscape alone. Partner with Moraph CRO Solutions. Let us handle the complexity of the digital domain so that you can focus on your true mandate: accelerating the path to approval.
​