Partnering will allow the contract research organisations (CRO) to benefit from the capabilities and geographical expertise possessed by the other company.
John Illingworth, manager director at Clinical Development & Support Services (CDSS), said this allows the partners to offer the benefits of working with a multinational CRO, while retaining the personal, tailored service associated with smaller firms.
US-based Medical Device Consultants (MDCI) will be able to offer clients services in Europe, and UK-based CDSS will have the option of referring sponsors to sites in North America.
Illingworth said the partnership is recognition that “clients need to ensure their clinical research plans meet international regulatory requirements especially in the US and Europe”. Partnering provides this to clients by providing both the infrastructure and local regulatory expertise.
MDCI recently completed an inspection by the US Food and Drug Administration (FDA), validating the quality of its operations. After auditing MDCI’s quality system, standard operating practices (SOP) and reviewing files for three active trials the FDA found no significant concerns.
Combined strengths
To best leverage their combined capabilities the partners will undertake mutual referrals, coordinated sales, marketing, and presentation activities.
Leslie Rose, director of clinical services at MDCI, said the companies were “former competitors” but now collaborating “to provide broader and deeper clinical and regulatory solutions for all of our medical device clients”.
MDCI will now benefit from “the CDSS network of employee and contract clinical research professionals in the UK and across Europe”, said Rose, adding that this “complements MDCI's full service CRO activities”.