Initial Engagement
​We are engaged for the setup of the EU trial, and begin working on a variety of contract positions within clinical operations, regulatory, medical writing and commercial.
Specialisms
Clinical Operations
Clinical Development
Medical
Regulatory Affairs
​
At the forefront of innovation and hypertension technology and on the cusp of launching the first EU trial of their lead product, this medical device start-up approached us in December 2017 to build out their entire European function and to offer guidance on the ideal infrastructure of their teams.
Being a small company of fewer than 15 employees at the time of engagement, the client was looking for a partner that could act as an extension of their permanent team, who could use their own expertise and sector knowledge when sourcing candidates, putting forward potential hires and advising on team structure.
Without feet on the ground locally, the client also needed support with onboarding candidates at such a large scale, as well as with navigating local compliance regulations within the six countries the trial was set to span. They were initially looking for a number of contractors across clinical, data management, safety and medical writing departments for a trial launch date in September 2018.
Project Timeline
-
DEC 2017
-
SEPT 2018
-
OCT 2018
-
JAN 2019
-
JUN 2019
-
SEPT 2019
-
JAN 2020
-
-
13 Contractors Appointed
​The first placements are appointed and begin work on the trial; 13 contractors to oversee operations across clinical, regulatory, data management, safety and medical writing departments.
-
Further Support in the US
​We are asked to provide further support as the trial begins. Two permanent positions at director level in the States, and various contractors for both the US and EU.
-
Major Funding and First Permanent Hires
After securing Series D funding amounting to over $70m, four candidates are placed into permanent positions. This includes a Director of Clinical Operations, a Director of Clinical Program Management and two CRAs.
-
Post-Market Trial Success
​The post-market clinical trial demonstrates success for the device, and we appoint two Field Clinical Specialists for the EU and US sites respectively.
-
Commercialisation Support
We source a Freelance Marketing Consultant to support the product commercialisation effort in the US, and the client's post-market trial demonstrates efficacy in resistant hypertension.
-
Further Commercial Support
We appoint a Reimbursement Consultant, appointed to establish the pricing and reimbursement strategy in various European markets.
Over an 8-month period, we took the client from having no EU presence to having 13 contractors across clinical, regulatory, data management, safety and medical writing departments in time for their Phase II trial launch in September 2018.
Since our success with the initial requirement, we've been engaged to provide continual support in further growing their EU teams as well as their already established presence in the US.
In a partnership that now spans more than three years, we have facilitated the placement of 45 contract and permanent staff across 8 countries. We also manage the ongoing legal and regulatory requirements of their contract workforce, with routine visa, insurance and right to work checks handled by our in-house contractor compliance department.