The 19th Precision in Clinical Trials (PCT) Summit – Amsterdam brought together a wide range of representatives from the life sciences industry, from large biopharma and CROs to small medtech companies and everyone in between. The format fostered networking among large biopharma companies, who might be looking for future investments or collaborations to access assets to fill gaps in their pipeline; smaller biopharma/biotech companies potentially looking for funding or collaborations with larger companies to take their platform or asset further; CROs hoping to market their services and find partners; and a range of companies with specific clinical trials services or products.
Representing Veranex at the event, Chrysanthi Matheou, Account Executive, appreciated the event’s approach to facilitating meaningful conversations between attendees. Discussed here, her key takeaways from meetings, conference sessions, and booth discussions included the shift toward a more strategic approach to outsourcing, the importance of actively listening to client needs, and how stakeholder engagement should guide technology use in clinical trials.
Through strategic outsourcing, sponsors gain access to additional capabilities while retaining closer study oversight.
Outsourcing continues to be a topic of interest in life sciences, as both an opportunity to supplement in-house capabilities and as a sticking point for sponsors who are increasingly wanting to maintain more control of their clinical trials. Delivered in small, fairly intimate settings, the conference presentations, many of which discussed outsourcing best practices, allowed the attendees to share their experiences openly. Seasoned biopharmas shared their knowledge with smaller companies just embarking into outsourced relationships, while CROs provided their insights around successful outsourcing processes, describing common mistakes they’ve seen and how oversight can be best conducted.
Hoping to gain greater visibility into study progress and control of study outcomes, many large biopharma companies appear to be internalizing many of the clinical trial functions they would have previously outsourced to a full-service CRO or services provider. At the same time, these biopharma companies recognize the challenges of building (and paying for) staffing and physical infrastructure to support all functions, particularly those beyond their core competencies.
The result is a more strategic approach to identifying the areas where outsourcing can provide value, by adding expertise or quickly scaling for a large, more complex project. As a result, partnership and outsourcing decisions are increasingly being conducted on a study-by-study basis, either to contract full-service CRO services or to just augment expertise for a specific geographic region, therapeutic area, trial design, or data management and statistical planning and execution. For the latter, data functions such as biometrics, large data warehouses, data governance, and data protection seem to be areas where many companies seek third-party providers.
Leading the conversation with questions about the sponsor’s needs provides valuable insights for the best-fit solution.
When product or service providers recognize that sponsors are coming to the table with this more strategic approach in mind, they can initiate better, more meaningful conversations by leading with questions around the pain points or challenges the sponsors are currently experiencing. Knowing what they need helps identify and tailor solutions and capabilities to provide the greatest value. Further, recognizing that the requirements for each company and study will differ can ensure that the questions are relevant to the situation, proactively inform whether your company’s capabilities are a good fit, and identify the level of support the sponsor might need.
For example, although our Data Management & Analytics team is capable of supporting companies of all sizes and our robust quality management structure can withstand even the most stringent of reviews, we find that the needs of small/emerging biopharma or medtech companies are those that we at Veranex are particularly well suited to meet. Our highly experienced team often provides the higher level of support and guidance needed across the spectrum of development by many smaller companies. Our therapeutic area expertise and specialized data management knowledge allow us to comprehensively understand the protocol and project requirements to provide thorough, expert advice about how to proceed for the best chances for success after regulatory submission.
Effective use of technology in clinical trials relies on stakeholder engagement and expert input.
Although the excitement for how new technologies and platforms could potentially transform and accelerate clinical trials is warranted, implementation planning is often lacking. Centralized data capture, electronic clinical outcome assessments (eCOAs), patient-generated data, and decentralized clinical trials are all fantastic in theory, but when used with the wrong population or in the incorrect setting, they can result in unnecessary expense, overburdened sites, and dissatisfied participants.
Before incorporating technology in a study design, it is worth engaging with stakeholders such as participants and investigators, and even technology vendors, to seek their input regarding the appropriateness, level of acceptance, and desire to use it. For example, participants with a serious disease such as heart failure could feel more comfortable with in-person visits and the reassurance that their doctor can provide. In this case, remote data collection might not be acceptable, is unnecessary, and could negatively impact participant retention.
We’ve also heard from companies that they’re unsure what they should outsource and what they should retain in house. Further complicating this decision is the vast number of providers of some services, creating uncertainty about whom to partner with, and the large number of key clinical trial solutions (often with largely different price points and feature lists). For sponsors unfamiliar with the nuances of, for example, different EDC providers, the choice with the most bells and whistles might seem like the safest choice. However, for a cardiovascular study with a 7-year follow-up, an EDC system with a $2000 monthly licensing fee quickly becomes a large study cost when more cost-effective alternatives also provide the required functionality. A trusted, knowledgeable partner can provide appropriate recommendations for the study design, budget, and timeline. Finding the right solution benefits everyone, and that’s the recipe for an effective, long-lasting relationship.
Open communication is central to strong partnerships.
Effective conversations between sponsors, CROs, and provider companies can help match the most pressing clinical trial challenges with the right solution(s). Many provider companies such as Veranex have the breadth and depth of expertise that can be particularly helpful for decision-making around the technology to use, when and how to use it, and how to establish scalable, adaptable systems. Our Data Management & Analytics team is always ready to chat and sees each new challenge as an opportunity to find the best-fit solution for our clients. Contact us today, or if you’ll be attending CTSS Boston, we’ll see you there!