EU perspectives: Keys to a winning sponsor/CRO partnership

October 8, 2019

Making waves in the clinical landscape can seem like a gargantuan task for all, from the smallest physician-led teams to the large global market leaders. Thus, these entities often turn towards Contract Research Organizations (CROs) to be a partner, resource, and support system, especially in the face of conducting global clinical trials across multiple, international geographies.

Syntactx is a unique CRO in that we are committed to staying true to the highest professional standard. This includes not falling victim to the traps that often plague other CROs, namely antiquated routines, poor data quality, and inexperienced staff. To ensure excellence we have developed the Syntactx Promise consisting of five principles (Precision, Expertise, Quality, Transparency, and Performance) that guide our interactions with the Sponsor.

To best illustrate how we can apply our five principles throughout the Sponsor’s journey with their CRO, I have delineated the four main parts of the engagement in the forthcoming paragraphs.

1. Getting to know one another

Every successful relationship begins with an introductory phase in which the two parties can learn more about each other. Transparency at this stage is imperative as it sets the foundation for a strong and lasting relationship. The Sponsor should use this opportunity to lay out their personal short- and long-term goals and expectations whilst detailing their various strengths and weaknesses. Conversely, the CRO can assess the available assets to determine how best to serve the needs of the client. At Syntactx, one of our many strengths is our team of clinical, analytical, and regulatory experts who help make this exchange productive and beneficial for all.

2. The planning phase

At the beginning of the project, the CRO should work with the Sponsor to precisely plan the budget and general project checkpoints. A risk-based quality management approach should be adopted to determine potential problem areas in the process that may require increased utilization of resource. This perspective is often utilized in the pharmaceutical industry to ensure optimal quality and performance. Additionally, we have many staff members with pharmaceutical experience who know how to best utilize this model of risk assessment and response. 

3. Executing the plan

This phase is often the longest and may occasionally require going back to planning phase or more colloquially “the drawing board.” Transparency remains imperative in this phase as the Sponsor and CRO should be kept abreast of any and all developments relating to the project, regardless of whether these updates are positive or negative in nature. A clear line of communication extending both ways is imperative for precision, quality, and performance.

As a CRO with extensive in-house expertise (numerous physicians, key open leaders, and experienced staff members), we use our available knowledge base to meet and ideally exceed every performance and quality outcome agreed upon in the previous phase. Additionally, we seek to ensure precision through a thorough overview process spearheaded by an expert. This procedure helps ensure reproducibility and avoid variability that may stem from the different staff members assigned to the task.

Our in-house Electronic Data Capture (EDC) system and other technological offerings further optimize the overall process and support transparency. In other words, the technology windows we create allow the Sponsor to stay informed at all stages of the engagement.

At Syntactx we work long days and weekends and will travel to any destination to ensure efficient and effective task completion. Our team is both knowledgeable and dedicated to achieving the Sponsor’s goals because we view them as our own goals.

4. Achieving the big picture goals

Our dedication extends past the delivery of the contracted item. We want the Sponsor to succeed in their long-term endeavors, which has previously involved anything from producing more publications to building a more extensive network. Regardless, we as an organization will continue to engage transparently with the client and use our expertise to precisely determine and execute the best next steps.

In conclusion, at Syntactx believe we are on one team with our client and are consequently committed to ensuring their, and accordingly our success. We are certain that our five principles will help us achieve success in this regard. Additionally, we are motivated by our clients because we know that their goals align with our mission, our vision, and our values: we are all hoping to affect generational change by transforming and elevating global health.

Four Main Steps of Sponsor/CRO Engagement