What is an Investigational Product (IP)?

An Investigational Product (IP) is a drug, biologic, or medical device that is being tested or used in a clinical trial to evaluate its safety, efficacy, or dosage. It can include new compounds, formulations, or approved treatments used in a different way under study conditions.

The IP is strictly controlled and monitored throughout the trial, from manufacture and packaging to storage, dispensing, and return or destruction, to ensure patient safety, protocol compliance, and regulatory adherence.

In clinical trials, RTSM helps maintain blinding, controls inventory, tracks shipments, and supports compliance by automating randomization and supply workflows in a secure, auditable manner.

Investigational products in clinical trials are primarily used at clinical trial sites such as hospitals, clinics, and research centers where they're stored and administered to participants during scheduled visits. In decentralized trials, they can be shipped directly to patients' homes for self-administration. These products move from manufacturing facilities through controlled distribution channels with strict temperature monitoring and tracking. They're used across all trial phases (Phase 1-4) to evaluate safety and efficacy, with healthcare professionals overseeing administration and maintaining detailed documentation throughout the process.

Specifically, RTSM is used to:

• Assign participants to treatment groups as part of the randomization process.
• Track investigational product inventory at each site.
• Manage drug shipments, returns, and dispensing to ensure the right treatment is given at the right time.
• Maintain blinding and compliance with protocol requirements.

By centralizing these functions, RTSM ensures accurate treatment allocation and efficient management of clinical trial supplies.

Clinion manages Investigational Products (IP) by integrating trial supply management with its clinical systems to ensure proper handling, dispensing, and tracking of investigational medicinal products. The platform supports I.P. administration by linking dosing schedules, subject visits, and randomization, ensuring that the right participant receives the correct treatment at the right time.

Through real-time inventory tracking, automated alerts, and audit-ready records, Clinion streamlines IP management, reduces manual errors, and maintains compliance with regulatory requirements throughout the clinical trial.

In real scenarios, Investigational Product (IP) management in Clinion shows a dashboard where sites and sponsors can track inventory, dosing, and administration for each participant. When a subject is scheduled for treatment, the system guides I.P. administration, ensuring the correct product, dose, and timing according to the protocol.

The platform also records all dispensing, returns, and inventory updates, creating an audit-ready trail. This allows study teams to monitor supply levels, prevent errors, and ensure that investigational medicinal products are used safely and efficiently throughout the trial.

Investigational Product (IP)

RTSM Software | Randomization & Trial Supply Management

Investigational Product (IP)