The Health Innovation Manchester-Industry Charter enhances the way we work with life science companies on their funded and sponsored clinical trials.

We wish to ensure participants are recruited to time and target, and the trials are initiated quickly and delivered efficiently and effectively.  Our HInM partners have worked collectively to streamline costing and contracting to further develop the efficiency of our clinical trial initiation.

The process includes:

• a standardised set-up cost (R&D set-up, research team enablement and archiving)
• agreed timescales for negotiation of costing and contracting
• an arbitration processes to resolve any issues in a timely fashion

While we are happy to review preliminary costs, contracts and protocols at the site selection stage, HInM partners have agreed to complete contracting and costing negotiations and be in a position to sign contracts within 20 calendar days of receipt of site selection.

To enable the HInM partners to work effectively, we expect our life science industry partners to:

• use unmodified Association of the British Pharmaceutical Industry (ABPI) endorsed model Clinical Trial Agreements (mCTA)
• provide timely responses during costing and contracting negotiations (working within our 20 calendar day time frame)
• accept our set-up fees
• maintain effective communication with organisations throughout the process without compromising usual working practices with sites
• recognise and accept that the start of the 70 day process is on receipt of full documentation and confirmation of site selection

If the clinical trial requires a modified, non-standard clinical trial agreement and the sponsor is unable to meet the accepted set-up fee and proposed trial costs, then we will not be able to guarantee the 20 calendar day target, as this requires additional time and resource to negotiate.

Set-up fee 

Our set-up fee is a universal pricing structure for the initiation of commercial clinical trials.  It represents a standard way of working and facilitates the set-up of clinical trials to the highest standards and agreed timescales. This fee can be negotiated if organisations are prepared to archive data.

In line with Department of Health targets, we expect costing, contract negotiations and sign-off of clinical trials to take a maximum of 20 calendar days from confirmation of site selection.  In the unlikely event that there are problems relating to clinical negotiations, escalation processes* are in place between our partner sites and the Greater Manchester Research Hub that allow for prompt resolution of issues.  This will also ensure that delays beyond the control of the trusts are rapidly identified and resolved.

Justification for PI/CI fees for The University of Manchester employed clinical academics involved in life science industry funded and sponsored trials

Our clinical academics are leaders in their fields, with credentials that have earned them national and international reputations as key opinion leaders. In addition to this, many have well defined and characterised patient cohorts, as a result of their academic activities, thereby leading to more reliable patient recruitment to clinical trials. These individuals have also contributed to our academic health science centre’s recognised standing as a Department of Health accredited centre of research excellence; an accolade afforded to only a few centres in the UK. We believe their association with any clinical trial will enhance the quality of the data collected and the reliability of delivery to time and target.