Ashfield’s partnership with “Client A” began in 2006 with case management for one marketed product and continues today for multiple products both post marketing and in clinical development Provision of case management services has expanded to include call center management; adverse event and product quality complaint intake and processing, preparation and submission of ICSRs and PADERs, literature search and reporting, trend and signal detection activities, and medical review and consultation. Additionally, Ashfield has developed SMPs and prepared IND Annual Reports for all clinical trials. We worked with Client A and their Affiliates to develop SDEAs, SOPs, and REMS documents. All Ashfield services have been provided domestically with no offshore support.
Our Safety Scientists deliver further support by providing Client A with “On Demand” support for the client’s Medical Science Liaisons (MSLs). Our PharmD or MD scientists with MSL experience partner with Client A as needed to provide medical and scientific information support at therapeutic area medical conferences. These scientists have also been engaged to develop SRLs and to respond to ad hoc medical information requests for which no SRL exists. This additional support has provided the client with the ability to scale up for specific activities without the need to hire additional staff. Since the Ashfield scientists have been involved with the client’s products for a long period of time, no product training is necessary to support the client in these activities as needed.
This client has also benefited from Ashfield support in the due diligence process for new product acquisition. An assigned medical expert has reviewed existing data for the potential acquisition product’s safety profile and identified any potential areas for risk.
Reflecting our values
Acting as an extension of our client, Ashfield has been able to provide expertise and scale up services to support their growth and success.