IMP Support and Management
Team specializations:
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We are a critical bridge, connecting with the CMC team, regulatory compliance, and working closely with clinical teams.
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Our IMP services include tailored support, whether in specific IMP steps or full project management, to meet the unique needs of our clients.
Our mission is to guide you in the management of your clinical supplies throughout the entire clinical trial journey. From defining trial needs to establishing the most efficient supply chain, we offer a versatile range of services
Our scope of work:
Global project management
Acting as an IMP manager, from provisional needs to monitoring clinical supply activities.
Define IMP requirements
Tailoring IMP requirements based on clinical trial protocols and CMC constraints such as product expiration, storage conditions, temperature monitoring, customs regulations, and CMO standards.
Labelling and packaging design
Writing texts for the labelling, including mandatory statements to be translated, define packaging to minimize waste and align with clinical protocol, and manage the resulting documentation.
CMO management for packaging and distribution
Advising and selecting CMO for IMP activities, including Request for Proposal.
Product certification, distribution strategy, and sponsor release monitoring
Ensure product certification, distribution returns handling and product reconciliation.