Contract Research Organisations (CROs) vary in capability, quality, experience, cost, and ease of collaboration. These can fundamentally impact the success of a clinical trial. This is why both the sponsor and the CRO must utilise their combined strengths to achieve their joint goal.
At PHARMExcel we believe the key to successful trial delivery is centred around five key elements:
PHARMExcel’s successful trial delivery is guided by our company values of Honesty and Transparency, Quality, Teamwork and Passion. All these elements are interrelated, equally important and form the basis of our partnerships with our clients. Aligning company values plays a significant role in fostering successful partnerships, and this is something PHARMExcel looks for early on.
When a sponsor chooses its CRO (and equally when a CRO chooses its sponsor) it’s imperative that working relationships are solidified and that roles and responsibilities established at the outset. Outlining ways of working, communication styles, and methods, in an open and transparent way, is critical for future success.
While many sponsors are well suited to take on certain aspects of the trial, such as the scientific know how, there are many elements that often need to be outsourced. At PHARMExcel we believe we are an extension of our sponsor. This is hugely beneficial in terms of easing resource burden on the sponsor, accelerating start up times, and ensuring time efficiencies can be achieved throughout the project which, in the long term, can help further accelerate their innovation to market.
A collaborative partner isn’t afraid to challenge the status quo in an honest and professional way. For example, PHARMExcel undertakes thorough and comprehensive reviews of its sponsor’s protocols before they are submitted to the authorities for approval. Using our previous experience and knowledge to ask questions ensures:
– the logistical delivery and timelines have been thought through
– the regulatory pathways are correct
– and the patient remains at the forefront of the trial.
We provide expertise based on previous feedback we have received from authorities, achieving a “first time right” submission. If we believe there are elements of the trial that would need further review to ensure overall delivery can be accomplished, we will have those conversations.
Having an open relationship with CRO staff that are as invested and passionate as the sponsor goes a long way to attaining successful sponsor -CRO relationships and positive study outcomes.
As the regulatory landscape continuously evolves and the bar for quality and compliance remains high, choosing the right CRO that puts quality at its heart is essential. Setting quality metrics and imbedding these into the trial delivery saves both time and money for our sponsor in the long term.
As an ISO 9001:2015 certified CRO, we take quality seriously! Our QMS supports all our trial activity and improves the quality of data we provide. We develop comprehensive Quality Plans for all our studies which outline key quality targets and metrics to realise. We share this openly with our sponsors throughout the study which gives them greater visibility and control over their study. We regularly undertake Trial Master File (TMF) QCs, and any formal regulatory package from first submission, through to amendments and safety reporting, undergo in-house QC review before submission, also shared with the sponsor.
Many start-ups, for example biotech and medtech sponsors, lack knowledge or experience in trial delivery. At PHARMExcel we are able to “hand hold” our clients through their journey and provide a real “value added’ approach. Our previous trial experience and our unprecedented knowledge in areas such as site feasibility gives us key metrics that are beneficial to our sponsor. For example, we can assist with trial site identification, enrolment numbers for a specific disease area, site compliance rates, and can bridge huge hurdles in the selection process when choosing a qualified site.
When choosing their CRO, the sponsor should think about where they wish to conduct the study. Local country nuances can cause significant setbacks if this is not considered appropriately.
As a full service CRO PHARMExcel has the ability to work across numerous speciality areas and across all phases of trial, including medical device trials. Our staff have over 100+ years combined experience and therefore we are able to carefully select the right team for each trial. It’s vital we get this match right, as the sponsor’s success is ultimately our success.
All sponsors will want to ensure their study runs in the most cost efficient, value for money way, whilst ensuring quality and compliance throughout. It’s important therefore that CROs provide transparent and realistic costs so sponsors can scrutinise and challenge where appropriate, before making their final selection. CROs should be able to justify their costs and demonstrate where monies will be spent. They should also provide flexible and innovative cost solutions for consideration. While low-cost proposals are often attractive, it may not account for all study specifications and may lead to higher unexpected costs down the road.
PHARMExcel does not undertake “factory” proposals. Each study is reviewed by our proposals team consisting of staff with expertise in that therapeutic indication. We are then able to comprehensively compile our proposals with sufficient detail so our sponsors can truly see how their study will be run, what the line-item costs are, and where additional costs may be incurred.
We also ensure we only charge for services that are really needed, providing a tailored service solution that retains the critical elements from the sponsor and provides the value-added elements from the CRO. Offering flexible payment options based on milestones and deliverables is also an important area we implement.
Although it should not be the case, some service providers show neither thoughtfulness nor responsiveness to their sponsors. It’s important that sponsors choose a CRO that will be fully committed to their needs and provides a loyal team that pays full attention to their requests. A medium-size, more agile CRO, like PHARMExcel, can often be a better option, particularly for start-ups. Oftentimes larger CROs may prioritise the larger projects leaving little or no room for the smaller trials.
It’s crucial therefore that sponsors feel they are getting appropriate attention and quick responses from day one, and this is a commitment PHARMExcel make to all our sponsors. From our RFP/proposal stage through to study end, we make sure our sponsors’ needs are addressed and we remain accessible and responsive.
"PHARMExcel has been a pleasure to work with, responsive and flexible."
Prof. S Faust (OBE), University of Southampton
When PHARMExcel was recently selected as the CRO to deliver a multi-centre hepatology study, we made sure from the start that we truly understood our sponsor and they understood us. We achieved this by spending time talking with various key staff to understand what their main drivers were and where their areas of concern were and evolved collaborative solutions for them. We challenged each other on various elements of delivery and sought mutual conclusions for the overall benefit of the project. We are proud of our staff’s “can do” attitude and we see this daily in their work. Our study/project managers embed themselves with the sponsor team and act as one. To date we have met all timelines and are confident of continued success!
Clinical trials are large projects involving substantial investments by sponsors and their teams. Having to change a CRO in the middle of a study is a risk that causes technical and financial problems for all concerned.
Every sponsor need is different and therefore it’s imperative that sponsors exercise care and attention in undertaking their CRO selections. Fostering a genuine sponsor-CRO partnership provides the greatest impact of all to any clinical trial. Together, with the scientific “know how” of the sponsor and the trial delivery expertise from the CRO, along with the characteristics outlined above, trial sponsors are in a prime position to seek out their long-term partner CRO.
And as we say at PHARMExcel, “Together we make it happen”.
"I have worked with other CROs on complex, multicentre trials and PHARMExcel has been by far the most effective in achieving targets and the easiest to work with on a day-to-day basis."
Dr Kim Orchard, Senior Lecturer and Consultant Haematologist University Hospital Southampton and CI for the TRALA study.
PHARMExcel is an award-winning, full-service Contract Research Organisation (CRO) providing a flexible and innovative approach to clinical trial delivery. The company is recognised for its in-depth knowledge and experience of the clinical research environment, particularly in the UK, and has a network of regulatory and industry associates, allowing it to provide a global reach.
Katie Howe, Head of Marketing
T: +44 (0)20 3642 6654
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