Keys to a successful Sponsor/CRO relationship

January 14, 2020

The State of CRO and Sponsor Relationships
The association between Study Sponsor and Clinical Research Organization (CRO) is increasing as outsourcing of clinical trials continues at a growing rate. Presently, outsourcing is less common in the medical device compared to the pharma industry (30% vs 70%) but is predicted to grow at a CAGR of 12.5%. (1,2) The increasing demands of clinical evidence and more sophisticated clinical trials by regulatory bodies will result in increased number of medical device trials and increased outsourcing of services like data management and analysis to CROs.

What are the benefits of a successful relationship?
The medical devices and pharmaceutical industries are becoming more and more competitive, requiring greater investments for successful innovation and drug discovery. With the pressure to bring new devices and drugs to market comes a higher workload and greater cost of clinical trials due to their size and complexity as well as a growing demand for post-market studies and real-world evidence. Transitioning all or part of this burden to a CRO has considerable benefit.

For the Sponsor

  • In the case of small start-ups and emerging companies, a CRO reduces or eliminates the need for a fully staffed Clinical Research Department which significantly lowers personnel costs
  • Efficiencies and proficiencies that a CRO offers to companies of all sizes may lower timelines and produce better quality of data
  • A CRO offers a broad range of value-added services such as protocol development, site management, payment schedules, core labs, regulatory expertise, sophisticated data capture and data monitoring systems
  • The Sponsor can focus on product innovation and other investment targets

For the CRO

  • Creates a joint ownership of the development of the device or drug
  • Shares common business metrics and goals
  • Knowledge and experience gained from a clinical trial is a benefit that goes directly to the CRO and may be passed to future projects from other sponsors

For Both (Mutual)

  • Formation of a trusted partnership to accomplish established deliverables and allow for innovation of drugs and devices
  • Creates a win-win scenario with the same objectives to bring improved health care to patients faster and more efficiently

What are the main challenges in developing and maintaining a relationship between Sponsor and CRO?
Lack of communication and transparency to all matters of a clinical trial are the common pitfalls in a Sponsor and CRO relationship. Clear communication and transparency between the two as well as putting the CRO in a core role is a must to build a sense of collaborative development.

For a Sponsor, sharing all the portfolio details allows a CRO to understand the priorities and be accountable for any negotiated outcome. For the CRO, a clear understanding of the priorities allows appropriate resources to be allocated and projects to be delivered with efficiency.

Differences in companies’ cultures and norms may present challenges in aligning common expectations and interests. There may be practical issues with the use of disparate tools and platforms for payment systems, data management, as well medical affairs integration and site relationships which can be stressful to the relationship.

Does CRO Size Matter?
An important consideration in choosing a CRO is finding one that functions as a full-service partner and can help a study sponsor from the inception of a product to market introduction and post-market studies. Larger CROs often provide a broad range of services at the cost of expertise in complex, highly specialized therapeutic areas as well as access to thought leaders in the space. In a recent survey, device companies prefer to engage with specialty/niche CROs specializing in medical device clinical trials at a preference level of 38% rather than global top CROs. (3)

What are the key processes and mechanisms to avoid conflict and work in a productive manner?
The keys to developing and maintaining the relationship between Sponsor and CRO include creating strategic partnerships in which both stakeholders having a vested interest. Ultimately, success requires open and transparent communications with the goal of building a collaborative long-lasting relationship built on trust and commitment.

What changes in the role of a CRO as it relates to its association with a Sponsor do you expect in the future?
New global regulatory requirements and greater attention to conflicts of interest have fostered an increasing need for outsourcing. The areas where outsourcing will be increasingly advantageous include safety assessments, core laboratory imaging analysis, data management and biostatistics, and monitoring of clinical site data.

The Syntactx Promise
As a leader in the CRO industry, Syntactx owes its success to establishing and maintaining true partnerships with its sponsors by ensuring precision in every engagement to meet the client’s specific needs, budgets and time-frames. A team of world class clinical, analytical and regulatory experts are accessible at every step of each project to achieve true collaboration. The passion for the quality of work that is delivered sets a high professional standard for the CRO industry. The Syntactx commitment to transparency and investment in sophisticated project management tools allow clients to monitor progress and communicate with team members at every step. Working together to set measurable goals and delivering on these goals consistently allows reliable performance and an enduring relationship. And with a team of dedicated physicians at the helm, we truly partner with clients to deliver the best possible outcome.

1. ISR Reports. February 12, 2015.
2. FierceCRO. (2013). Devicemakers should rely more upon outsourcing and CROs, study says. Retrieved 2016, from FierceCRO: http://www.fiercecro.com/r-d/devicemakers-should-rely-more-upon-outsourcing-and-cros-study-says
3. https://www.medicaldesignandoutsourcing.com/industry-practices-in-medical-device-cro-outsourcing/