A successful protocol requires management and delivery of comparator products to investigator sites worldwide. Sourcing comparator products represents a challenge to clinical leads today looking to find materials from suppliers. However, the main challenges arise after the acquisition of the products. Products must meet local regulations for global shipment, must be packaged for clinical use, must demonstrate equivalence and authenticity and must be monitored for expiry at a global level. As a result, today’s protocols require management of comparator materials through one source to build a global supply chain and monitor developments from start to finish.

Ancillare provides the services needed to succeed in today’s most complicated protocols. We have a proven track record in managing clinical materials on-time and on-budget with all documentation, labels and packaging required for global distribution. We are DEA licensed for Class II through V clinical materials and our facilities include ISO Class 8 secure clean rooms to manage the supply of products to investigator sites throughout the protocol. We are equipped to handle the largest comparator specifications and contain the specialized expertise needed for the smallest, single-use applications. By managing the process through one source, Ancillare is able to acquire, inspect, document, ship, track and monitor usage of clinical materials at a global level.

At Ancillare, we manage the flow of comparator products from start to finish to ensure that protocol requirements are met and that investigator sites have the materials needed to succeed in today’s complex clinical environment.

Our proven services include:

	Recommendation, selection, procurement, inventory, monitoring and distribution of API products, Biopharmaceuticals, Medical and Healthcare Devices and Comparator Drugs
	DEA Class II-V License to source branded, generic and OTC products in all therapeutic classes and dosage forms
	JIT supply of clinical materials to investigator site locations worldwide
	Sourcing for both large and small projects
	Monitored, secure and validated CGMP and ISO 14644 compliant state of the art facilities including ISO Class 8 clean rooms, ambient, clean and cold storage
	Kitting, storage, shipping and resupply of clinical materials worldwide
	Proprietary, validated ERP system to track clinical materials globally
	Tracking of products throughout the supply chain including import requirements, lot, batch, expiry and usage notifications
	Regulatory and compliance services including labeling, documentation and equivalence to meet EU, EC and WHO Annex 13 Guidelines
	Reporting services for usage, expiry and trend analysis at a global level

Ancillare provides the comparator services needed by clinical leads when designing, implementing or evaluating global protocols. Our expertise and services provide the resources necessary for success in protocols of all sizes and therapeutic areas.