To enhance the way MAHSC partners work with the Life Science Industry on their funded and sponsored clinical trials, we have developed the MAHSC-Industry Charter.
The MAHSC-Industry Charter
Manchester Academic Health Science Centre (MAHSC) is home to a critical mass of internationally recognised biomedical researchers, state of the art research infrastructure and well-established patient cohorts that work to consistently deliver clinical trials to the highest standards. MAHSC is committed to ensuring it is the best location in the UK for conducting life science industry clinical trials.
We acknowledge and actively wish to meet the requirements of our Life Science Industry partners to ensure their clinical trials are initiated quickly and that participants are recruited as agreed during the feasibility stage of MAHSC site selection to time and target. Facilitated by the Greater Manchester Research Hub, initiation and delivery of clinical trials is a high priority and our research workforce is focused on delivering clinical trials efficiently and effectively.
To ensure efficient initiation of clinical trials, our partners have worked collectively to streamline costing and contracting activities.
The processes include:
- A standardised set up cost,
- Agreed timescales for negotiation for costing and contracting where the Greater Manchester Research Hub will monitor the effectiveness of these processes on behalf of the MAHSC organisations.
- An arbitration processes is in place to provide further assurance to our Life Science Industry Partners that any issues that arise can be resolved in a timely fashion.
While we are happy to review preliminary costs, contracts and protocols at the site selection stage all MAHSC partners have agreed to complete contracting and costing negotiations and be in a position to sign contracts within 20-calendar days of receipt of a valid R&D application (VRA).
In order to enable the MAHSC partners to work effectively, we expect our Life Science Industry partners to:
- Use unmodified ABPI endorsed model clinical trial agreements (mCTA)
- To provide timely responses during costing and contracting negotiations (working within our 20-calendar day timeframe)
- Accept MAHSC set up fees
- To maintain effective communication throughout the process with organisations without changing usual working practices with sites
- To recognise and accept that the start of the 70 day process is on receipt of full documentation and a valid R&D application (VRA)
If the clinical trial requires a modified, non-standard clinical trial agreement and the sponsor is unable to meet the accepted MAHSC set up fee and proposed trial costs then the MAHSC partnership will not be able to guarantee the 20-calendar day target due to this requiring additional time and resource to negotiate.
The MAHSC Set Up Fee (Applicable to MAHSC Organisations Only)
The MAHSC set up fee was established following a request from Industry working with our organisations to address the variation in set up fees across our partnership. They could not understand why separate organisations within a single Academic Health Science Centre all had different set up fees.
The MAHSC set up fee has been established across all MAHSC partners and all have been using it for Life Science Industry sponsored and funded clinical trials. The fee does not apply to Investigator Initiated clinical trials
It is not a separate set up that comes directly to MAHSC. All of the set up fee goes directly to the individual trust – MAHSC CLG does not receive any part of it.
It represents a standard way of working across all organisations within the Manchester Academic Health Science Centre to set up clinical trials to the highest standards and to agreed timescales
It does not distinguish between type of study be it a Phase I first in man, or a simple questionnaire study.
If companies are prepared to archive the set up fee can be reduced
It represents a ‘kite mark’ of quality that you can expect from a Department of Health Accredited Academic Health Science Centre, of which Manchester is one of only six in the UK and the only Academic Health Science Centre outside the South East of the country.
Whilst MAHSC partners often undertake clinical trials independently of one another, we have established a universal pricing structure for the set up and administration of standard services – the MAHSC set up cost. This cost (covering R&D set up, Research Team Enablement set up and archiving fees) reflects the research pedigree of MAHSC organisations and ensures parity across the partnership for industry. This cost also provides our external partners with assurance that life science industry clinical trials are set up to exactly the same standard and agreed timescales no matter which MAHSC partner is involved in the trial.
In line with Department of Health targets, we expect costing, contract negotiations and sign off to take a maximum of 20 calendar days from receipt of a valid R&D application for a MAHSC site participating in a commercial clinical trial. This assurance assumes that delays are not caused by Industry sponsors/CROs. There is an expectation that companies will use an unmodified version of the model clinical trials agreement (mCTA).
In the unlikely event there are problems relating to negotiating a clinical trial, 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.
University of Manchester Clinical-Academics Involvement in Life Science Industry Funded and Sponsored Clinical Trials
Justification for PI/CI fees for University of Manchester employed Clinical Academics
Our clinical-academics are leaders in their fields of specialty with academic credentials, and national and international reputations as key opinion leaders. In addition to this, they often have well defined and characterised patient cohorts as result of their academic activities thereby leading to more reliable patient recruitment to any clinical trial. These individuals have also contributed to MAHSCs recognised standing as a Department of Health accredited centre of research excellence (an accolade given to only a few centres in the UK). We are extremely proud of their achievements and years of experience and as such we believe their association with any clinical trial will in fact enhance the quality of the data collected and the reliability of delivery to time and target.