Case Study
Deliverables
Illuminate (AKA Discovery & Understanding)
Outside the world of big pharma, today’s clinical trial sponsors want to be able to pivot towards new directions in an agile manner, updating their methodology in the light of new information.
In the traditional model, however, it can take a CRO 2 months or more to act on something you requested last week, never mind them being able to react to new data as it comes in.
We gain an upfront understanding of your requirements in order to provide you with a roadmap for selecting the right CRO and vendors for you – those that will be able to adapt and respond quickly, without requiring multiple change orders and amendments to be authorized beforehand.
Project Ignition (AKA RFP)
The RFP process is a familiar one that often gets bogged-down with a large amount of detail and provides a thinly-veiled sales pitch from the potential partners.
Our approach is to consider the RFP process as a part of the whole – ensuring the right partners are in place for igniting the project with maximum enthusiasm and clarity* on how to get things right first time.
Of course, when it comes to detail, you can’t afford to miss things that could result in wasted time and resource at a future stage. Our line by line scrutiny and clarification of proposed activities helps identify and resolve potential issues before they become a problem later on.
We helped a large biotech company review its RFP’s to develop a 93% higher focus on patient recruitment – one of their biggest challenges – than had been put forward by the vendors. This approach also incorporated a company personality-based shift in emphasis from 66% of the questions being aligned with ‘what’ will be done, to ‘how’ the goals of the project will be achieved. (Jolting some of the vendors out of their comfort zone, and thus avoiding a cookie cutter approach to the responses).
Project Partnership Meetings (AKA Bid Defense)
The very term ‘bid defense’ is inherently combative, with one side feeling it needs to defend and justify its proposal against the other – presumably in ‘attack’ mode.
We don’t believe this is the most effective way of building a fruitful and collaborative partnership from the outset.
Our innovative and wholly new approach to structuring bid defense meetings – henceforth to be known as Project Partnership Meetings – enables a spirit of co-creation and teamwork from the very first moment.
Gone will be the days when your procurement department had to sit through hours of sales pitch and examining the minutiae of a proposal to justify why it should be included. (With pretty much nobody enjoying the meetings and often considering them a complete waste of their time).
Instead, you’ll be taking part in a mutually-beneficial process – based on defining clarity* for real world elements that are likely to come up in your trial. The people in the meeting being there to ‘roll up their sleeves’ and get stuck in to developing a proper project plan, rather than simply being there because they feel they have to.
We led roleplay-based scenarios that helped a large biotech company predict what might go wrong such that they developed a robust contingency plan and pre-defined costings and early warning trigger points, saving them over 30 days of input for revisions and change orders.
Co-creation/ Onboarding (AKA Kick-Off)
Emerging from the Project Partnership meeting should be a well thought out strategic plan for your study.
The next step, then, is to build on this with something of real value – not just the traditional interminable kick-off meet where everyone introduces themselves and many are not really sure why they are there in the first place.
Guiding your onboarding process such that it is based on a true spirit of clarity* and co-creation will help embed your partners in the project so that they are as enthusiastic and outcomes-focused as you.
Traditional models are based on a transactional approach such that any deviation from the defined plan results in additional time and costs. True co-creation is based on an adaptive and agile methodology that is more fluid and reactive to changing circumstances.
We worked with a large pharma and their solutions providers to agree and cap the total number of monitoring visits throughout the study, with shared ownership and responsibility for targeted use of resource spread throughout the study, rather than front-loaded. (Thus decreasing accelerated burn rate).
Stewardship Oversight & Governance
Even well-developed project plans with solid foundations and mutual buy-in from everyone involved can run into problems.
That’s where effective stewardship of your projects and your relationships can help save time and resources as you implement your strategy ongoing.
Spotting things before they are likely to become a problem is a key element here, with a series of milestones and measurements being put in place from the outset to ensure things run smoothly throughout.
Guidance and nudging things back on course may be required for delivering best outcomes. But the roadmap and guardrails that have been developed from the start will ensure the input required to keep your projects on track is minimal and has no detrimental impact on results.
An ongoing patient recruitment campaign for a small pharma co required a strong plan at the outset, but also an ongoing system of checks and balances such that it could evolve in real time in the real world. Eventually delivering the target number of randomized patients without having to increase time and costs through scope changes.
