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Early Drug Development by Outsourcing Analytical Services

By ESOutlook | Monday, March 12, 2018

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There are various criteria used to select a service provider depending on the scope of work being requested. When it comes to the early phase drug development, diverse factors such as skills/knowledge, resource availability, and customer needs determine the criteria for choosing a partner or service provider for analytical services. There are certain ‘table stakes’ for a service provider to be considered, and those usually relate to regulatory compliance, scientific knowledge/experience of the study directors, communication, and prior experience or reputation. In order to select the perfect analytical service provider for early phase development studies, detailed discussions between client and provider are necessary to ensure the requirements of both the parties are met.

Once the preliminary steps are carried out, the following must be considered:

• Resource availability—a project plan should be detailed with all activities and delivery dates to ensure that the services are provided within the required timeframe.

• It is also important to maintain clarity about the required documentation by the service provider and its compliance for any regulatory submissions.

• Whether the service provider will provide regular updates and the format of these updates--regular telephone conferences.

• Whether the service provider can provide all services in-house or would parts be subcontracted. If subcontracted, does the service provider have a subcontract lab in place to perform these tasks?

Once the required service is defined, the selection criteria hierarchy covers schedule, quality, and then price. For more commoditized studies, the ordering may be price, schedule, and then quality.

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