Our CS module helps to navigate the complex regulations that govern the use of drugs and controlled substances for research purposes.

Ensure Regulatory Compliance

Monitor and manage the use of controlled substances in research, ensuring adherence to DEA and other regulatory requirements.

Streamline Protocol Approvals

Create and submit detailed protocol applications to the Controlled Substances Advisory Committee quickly and accurately.

Integrate Seamlessly

Connect the Controlled Substances module with CSC, IRB, SCRO, RSC, and IBC for consistent compliance across systems.

Simplify Documentation

Go paperless with license renewals, amendments, and reviews, reducing time and effort compared to manual processes.

Connect CS Module Across Your Data Systems Without Any IT Complexity

Effortlessly connect the Controlled Substances module with your current compliance systems like IRB, IACUC, and research administration. Whether it’s clinical trial management or quality assurance, our platform's open architecture ensures smooth integration, giving you quick access to the real-time data you need without adding complexity for your IT team.

Our Research
Compliance Modules

IRB (Institutional Review Board)

Optimize the IRB compliance process to minimize investigator, coordinator, and committee effort while ensuring stringent approval protocols and risk mitigation.

IACUC (Institutional Animal Care & Use Committee)

Facilitate the review and monitoring of all animal research protocols, ensuring full compliance with IACUC regulations for both USDA and non-USDA species.

IBC (Institutional Biosafety Committee)

Protect personnel, human subjects, and society from biohazards by efficiently reviewing research protocols involving carcinogens, infectious agents, and allergens.

SCRO (Stem Cell Research Oversight)

Streamline the approval and documentation process for stem cell research, ensuring consistent oversight and compliance with SCRO guidelines.

CSC (Chemical Safety Committee)

Simplify CSC compliance by automating protocol submissions, ensuring safer use of hazardous chemicals and stronger oversight in research environments.

RSC (Radiation Safety Committee)

Ensure safe and compliant use of radioactive materials in research through structured RSC protocol review and enforcement.

PAM (Post-Approval Monitoring)

Facilitate regular inspections of approved protocols and swiftly implement corrective actions to ensure continuous compliance with established safety and research standards.

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Frequently Asked Questions

1. How does the PAM module help with compliance tracking?

The PAM module provides real-time monitoring capabilities through intuitive dashboards, offering immediate visibility into the status of all approved protocols. It ensures thorough oversight by tracking activities and findings across protocols, helping you stay compliant at all times. Additionally, it maintains detailed audit trails for easy access during regulatory inspections.

2. How does the PAM module support amendment protocols?

The PAM module simplifies the process of submitting amendment protocols by automating the workflow. When monitoring findings highlight necessary changes, it enables investigators to quickly and accurately submit the required amendments to address compliance issues, ensuring that any adjustments are properly documented and promptly addressed.

3. How does PAM ensure regulatory inspection readiness?

PAM maintains comprehensive monitoring documentation and audit trails, ensuring that all protocol activities are well-documented and easily accessible during regulatory inspections. This eliminates the risk of missing key compliance records and ensures you're always inspection-ready.

4. What support does PAM provide for smaller research teams or institutions?

For smaller teams or independent research institutions, PAM simplifies post-approval monitoring workflows by automating routine tasks, tracking findings, and sending reminders. This helps reduce the administrative burden, allowing smaller teams to focus on high-priority research tasks while ensuring compliance with relevant regulations.

5. How does PAM help improve team productivity and collaboration?

The PAM module enhances team productivity by automating monitoring tasks, ensuring that inspection teams are assigned to the right protocols at the right time. It also facilitates cross-departmental collaboration by providing centralized oversight and improving coordination, especially in large institutions such as universities or multi-site research organizations.

6. How does PAM support compliance with specific regulations, like the FDA or the EMA?

PAM supports compliance with global regulatory requirements by ensuring that all monitoring activities align with guidelines from organizations such as the FDA, EMA, and ICH. It helps track activities, findings, and corrective actions that meet these standards, safeguarding your research against regulatory risks.

7. How does PAM integrate with existing IRB, IACUC, or other compliance modules?

The PAM module integrates seamlessly with your existing IRB, IACUC, and other research compliance modules, ensuring a unified, end-to-end monitoring system. This integration enables comprehensive oversight of all research protocols, facilitating easier tracking of findings, management of corrective actions, and ensuring compliance throughout the entire research lifecycle.

Discover What an Intelligent Integrated Research Compliance Platform Can Do For You

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