Many small to mid-sized biotechs experience challenges with being understood by the large CRO’s. The requirement for flexibility and agility, plus the evolving and adaptive nature of their trial designs, was often lost in the traditional method of selecting and sourcing partners. From the start of the project, the ClinEco team identified a need for external expertise to streamline the outsourcing strategy. As a result, ClinOpsClarity was brought in to provide clarity and support for the biotech’s operational needs.
“It was great to find the team at ClinOpsClarity with the help of ClinEco. It was a joy to work with them on redefining our outsourcing strategy. They went to great lengths to really understand our organization and help us gain clarity on what we want from our partner and supplier relationships.”
Quote from the Sponsor’s Director of Clinical Outsourcing
Facing the Problem
In the world of pharma outsourcing, it is well-known that everyone ‘plays the game’ when it comes to evaluating RFPs from potential CROs – especially those from larger organizations. Essentially, as the CRO is likely to make most of its profit from the ongoing changes in the contract scope that inevitably occur, they often low-ball their fee in the initial offer, intending to capitalize on additional fees from change orders.
Being an organization interested in reducing waste and cost while improving efficiency, the sponsor was tired of this approach. Despite many of their employees coming from the world of big pharma, they wanted to look at a new way of working. One that offered full transparency from the outset from both parties, with the necessary elements of flexibility and agility already built in.
When discussions are not held up front about how teams prefer to work, including their needs for flexibility, the traditional task-based approach often leads to a reactive partnership resulting in blame and consequently the micromanagement of partners when things go wrong – as they inevitably do. The biotech company was keen to start fresh with a true partnership arrangement, investing time up front in establishing the right tone, expectations, its need for agility, and conditions rather than one of traditional sponsor and supplier.
Developing the Solution – ClinEco and ClinOpsClarity
The first step was to gain a thorough understanding of the company’s core way of working and specific needs to deliver the best approach to fit their circumstances.
The selection of potential partners usually comes at a time when there are lots of other things going on, often leading to a chaotic, reactive, and haphazard approach that ultimately proves unsatisfactory. ClinOpsClarity helped the biotech through this stage without imposing or distracting from the essential activities by focusing on cultural fit – ultimately saving a lot of time and resources for the future and providing a fresh approach for imminent projects.
In parallel, the biotech company onboarded a large team to ClinEco’s platform, led by the Director of Clinical Outsourcing, who acted as the admin and team lead. This team included key roles such as Clinical Operations Managers, Procurement Specialists, and Trial Coordinators, each using ClinEco to research potential partners. The platform allowed the team to publish several Request Alerts, which generated promising replies and introduced new partnership opportunities.
Additionally, the biotech team took advantage of ClinEco’s Vendor Management Widget to streamline CRO selection and track vendor performance. This tool proved essential in helping the company maintain a clear and efficient overview of their vendor relationships. Specific questions related to vendor selection were also directed to ClinEco’s Luminaries, whose expert input was instrumental in guiding decision-making processes.
ClinEco’s platform was particularly beneficial for studies conducted in the APAC region, providing localized expertise and connections that were critical to the success of those projects.
The biotech company then worked with ClinOpsClarity, investing a short amount of time upfront to save significant time during the outsourcing process and beyond. By thoroughly understanding the sponsor’s culture and needs early on, they ensured the later stages would run more smoothly, with fewer delays, misunderstandings, and unexpected challenges, leading to a more efficient, optimized collaboration and fewer changes in scope.
A key piece of the puzzle that was uncovered was to help the sponsor position itself in such a way that their personality could be expressed to potential partners at the beginning of the relationship. This resulted in a new overall tagline for the company when positioning itself externally – ‘We’re not like big pharma, not because we are small, but because we do things differently. Show us how you can help us do things differently and get treatments to patients faster …’
It also became clear that the transactional nature of the usual supplier sourcing process was not something that would work, so ClinOpsClarity helped reframe the process such that it was more akin to a job interview (or even a marriage) where both parties are determining whether they’re a good fit for the other. The principles of co-creation were built into the framework, so that the biotech and its partners are all working toward the same goal, placing much greater emphasis on how the partnership would work – focusing on proactivity, innovation, problem-solving, and agility, rather than just what would be delivered.
As a result of this approach, the projected number of change orders was reduced by 40-50%. The increased clarity from the outset helped to eliminate change orders that everyone in the process normally subconsciously accepts as ‘a given.’ This was achieved through more transparency and honesty about the overall process, with everyone having a stake in its success through co-creation.
A key message to convey was that the sponsor company is a learning organization and was keen to hear alternative ideas on how to approach challenges (e.g., in delivering adaptive trial designs).
Embedding a partnership-style arrangement from the outset was also something that required assistance to gain buy-in – both internally at the biotech and from the potential partners – an outcome ClinOpsClarity was able to deliver through education, setting clear expectations, and keeping the project on track in an effective, but unobtrusive manner.
Another area that was identified for ‘cutting through the noise’ was to shift emphasis from the standard 40+ page ‘bid grids’ – which can lead to simply becoming so bogged down in detail that more important wider issue factors are missed. Far more important would be to build a set of bespoke solutions together, with regular reviews and the flexibility to pivot quickly if things aren’t working out as they should.
The shared risk that comes from co-creation was another key benefit of the approach. This is not about innovation for its own sake but about creating new ideas that can be monitored and swiftly revised if they fall short of the desired results. With both parties invested in the outcome, the partnership becomes a dynamic, adaptable process that benefits everyone involved.
Utilizing the ClinEco Platform
All of this was made possible through the use of the ClinEco global clinical trials ecosystem. ClinEco is the first and only online ClinEco is the first and only online community and marketplace, purpose-built for the clinical research industry and designed to make finding partners and collaborators faster and more straightforward. As well as being a platform featuring a wide range of industry specialist partners, ClinEco provides the ability to keep all the relevant information in one place via a secure sponsor repository, thus being a one-stop environment for potential partner identification, engagement, and administration to support an outsourcing strategy.
The Results of Streamlined Outsourcing
As well as a completely new approach that fits better with how the biotech operates, the project resulted in an entirely new style of RFP being developed – one that enables both client and partner to understand each other’s requirements in such a way that the relationship can begin with full transparency and in the spirit of co-creation, i.e., partners working closely together, with a deep understanding of what each party requires, to design, develop and implement an optimal outcome.
A further iteration of this was a revised approach to traditional bid defense meetings (the word ‘defense’ automatically implying a combative process rather than a collaborative one). In their place, ClinOpsClarity helped devise a Project Partnership meeting. One based on scrapping the traditional focus on procurement-led discussions and generic sales pitches and replacing it with scenario-based ‘let’s roll up our sleeves’ activities – working together to create a plan that everyone is enthusiastic about delivering. (An approach that forward-thinking CROs are equally keen to adopt, rather than sitting through yet another half-day meeting that they can probably predict will be a waste of time from the outset).
“We were initially shocked by the way this biotech company approached the process of selecting us as their CRO. Having gone through the process, though, we’re delighted that it’s helped us redefine our own relationship with client partners and will be adopting this approach ongoing.”
Head of Partnerships, Global CRO
Continuing into the Future
Having started from the traditional method of supplier outsourcing, then developing a framework for a truly co-creative partnership system to be in place, the next step is to ensure this approach is embedded throughout the biotech company and its partner organizations. Ultimately leading to substantial savings in time and resources and achieving the goal of getting treatments to patients more quickly.
About ClinEco
ClinEco (short for Clinical Ecosystem) is a web-based platform and community that connects all the stakeholders of decentralized, hybrid and conventional clinical trials. ClinEco unites sponsors, CROs, service providers, and sites on the world’s largest clinical trial marketplace enabling everyone to explore, engage, and exchange capabilities with their own ecosystem of partners.
https://clineco.io/
About ClinOpsClarity
ClinOpsClarity help small to medium size pharma to be understood in order to find the right partners to achieve the best results for their projects. This increased level of clarity leads to cost savings and time reduction throughout the clinical trial outsourcing process and beyond.
https://clinopsclarity.com
