Effective IMP Management for Clinical Trials

Ensure the success of your clinical trials with Synapmed’s expert IMP management services. We handle all aspects of IMP sourcing, distribution, and accountability, maintaining compliance and operational efficiency. Our commitment enhances trial integrity and accelerates timelines for better patient outcomes.

Streamlining IMP Management with Precision and Compliance

At Synapmed, we utilize cutting-edge technology and industry best practices to streamline IMP management. Our robust systems and experienced professionals ensure that every aspect of IMP handling—from temperature monitoring to accountability—is conducted with the highest level of accuracy and compliance. Explore the use cases below to see how Synapmed enhances IMP management throughout the drug development process.

Efficiently manage your IMPs from source to site

Identify and source quality IMPs for global trial sites
Coordinate logistics to ensure timely distribution while adhering to temperature controls
Assess and select suppliers based on quality and regulatory compliance
Implement tracking systems for real-time visibility into the supply chain

Protect product integrity with precise monitoring

Implement real-time tracking systems for temperature control
Maintain rigorous documentation and conduct reconciliations for accurate inventory management
Establish thresholds for temperature excursions and initiate corrective procedures
Train staff on proper handling and storage procedures to ensure compliance

Proactively address issues and ensure compliance

Develop strategies for identifying and addressing deviations quickly
Provide guidance on regulatory requirements for IMP handling and support documentation needs
Conduct regular training sessions to keep staff informed of compliance standards
Implement a feedback loop for continuous improvement in deviation management processes

Ensure safe and compliant disposal of IMPs

Follow regulated procedures for the destruction of IMPs post-trial
Adhere to environmental and safety standards in all disposal activities
Maintain accurate records of destruction processes for audit purposes
Partner with certified waste disposal companies to ensure compliance with local regulations

why synapmed?

Synapmed’s IMP Management services deliver comprehensive and expert support to pharmaceutical companies navigating the complexities of investigational medicinal product management.

Our dedicated team and advanced technology simplify IMP sourcing, distribution, and accountability, ensuring adherence to regulatory standards. By enhancing operational efficiency and maintaining strict compliance, we empower our clients to communicate product value effectively, streamline clinical trial processes, and ultimately improve patient outcomes.

Synapmed’s commitment to accuracy, compliance, and operational excellence allows you to focus on advancing healthcare innovation.

Frequently asked questions

What is investigational medicinal product (IMP) management?

Investigational medicinal product management involves overseeing all processes related to the sourcing, distribution, and accountability of IMPs during clinical trials. This includes ensuring compliance with regulatory requirements, monitoring temperatures, and managing documentation.

What are the key components of effective IMP management?

Effective IMP management encompasses several key components: proper sourcing and distribution of IMPs, rigorous temperature monitoring, meticulous documentation and reconciliation, proactive deviation management, and compliant destruction and disposal of products post-trial.

How does temperature monitoring work in IMP management?

Temperature monitoring involves implementing real-time tracking systems to ensure that IMPs are stored and transported within specified temperature ranges, thereby maintaining product integrity and compliance throughout the clinical trial process.

How does deviation management work in IMP management?

Deviation management in IMP management involves identifying, documenting, and addressing any discrepancies from established protocols. This includes developing corrective action plans to mitigate the impact of deviations and ensure compliance with regulatory expectations.

What are the regulatory requirements for IMP management?

Regulatory requirements for IMP management vary by region but generally include guidelines for sourcing, storage, transportation, documentation, and disposal of investigational products. Compliance with these regulations is essential to ensure patient safety and trial integrity.

Why is documentation important in IMP management?

Documentation is crucial in IMP management as it provides a complete record of all activities related to the handling of investigational products. This includes sourcing, distribution, temperature monitoring, and disposal, ensuring transparency and compliance for audits and inspections.

How do you ensure quality control in IMP management?

Quality control in IMP management is ensured through regular audits, adherence to standard operating procedures (SOPs), staff training, and the implementation of quality management systems to identify and rectify any potential issues.

What role do stakeholders play in IMP management?

Stakeholders, including clinical trial sponsors, investigators, and regulatory authorities, play a crucial role in IMP management by ensuring that the study complies with all regulations and that the investigational products are handled correctly throughout the trial.

How does Synapmed support IMP management in clinical trials?

Synapmed offers a range of IMP management CRO services designed to streamline clinical trial processes. Our services include IMP sourcing, temperature monitoring, accountability tracking, deviation management, and disposal, all tailored to meet regulatory standards and support successful trial outcomes.

What are the benefits of using Synapmed’s IMP management services?

Using Synapmed’s IMP management services offers several benefits, including enhanced operational efficiency, reduced risk of compliance issues, improved communication of product value, and ultimately, better patient outcomes during clinical trials.

“Synapmed allows us to build expertise within our company while also outsourcing the administrative aspects. When you work with most vendors, it becomes an assembly line, and quality goes down. Or they take over completely, and we lose oversight. Synapmed is a part of my team, so we get to maintain and retain the quality.” 

“I build and fix departments and Synapmed has been part of that journey with me. We wanted to come up with a safety profile for one of our drugs. Because of the performance of competitor generics, it was getting a bad name. Synapmed mined the data, analyzed our product versus generics from a safety perspective, and wrote an article and abstract on the findings that was very productive.”

What is the Right Outsourcing Strategy for Your Company? Not One Model Fits All

Pharmacovigilance (PV) is crucial for the pharmaceutical and biotech industries as safety regulations grow increasingly complex. Companies encounter challenges in managing rising data volumes, resulting in higher costs and a need for specialized expertise. In response, many organizations are outsourcing PV functions to cut costs and tap into expert knowledge. Successful outsourcing hinges on careful partner selection aligned with specific needs, while retaining essential tasks in-housed when necessary. By effectively managing these partnerships, companies can navigate the complexities of pharmacovigilance while concentrating on their core competencies.

Dedicated to youR Project

No matter the size or scope of your projects, you have a committed partnership team with Synapmed. A team that listens, pays attention to details, and brings smart insights to the table. All so you can solve real problems throughout the product development and commercialization lifecycle.

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