Knowledge is Power

5 Important Questions You Should Ask Your Sales Rep

How to ensure your prospective provider meets the gold standard for operations and data collection in medical imaging, cardiac safety, and eCOA

Eric Forsthoffer – SVP Global Business Development at Clario

Clinical trials demand precision, scientific expertise, and unwavering attention to detail. When selecting the right provider for your trial and your patients, asking the right questions during the sales process can make all the difference. Here are the top five considerations to guide your vendor selection:

What’s their approach to imaging in trials?

Understanding a core lab’s imaging approach requires examining their experience, organizational strategies, and procedural efficiency. It’s imperative to ask about:

1. Their depth of experience in imaging within clinical trials, particularly concerning imaging endpoints and criteria selection.
2. How they organize central reads, including the use of in-house or external readers.
3. The efficiency of their image uploading process and the comprehensiveness of their site training.

Partnering with an experienced core lab is crucial to navigate the complexities of imaging in clinical trials to ensure the optimal organization of central reads and efficient image uploading processes.

How robust is their experience and expertise?

Knowing the vendor’s history and credentials can give you a better idea of its capabilities. It’s a good sign if they have:

1. A strong track record of regulatory approvals in varying therapeutic areas and aspects such as safety, efficacy, and quality of life.
2. A team equipped with scientific expertise in that therapeutic area and indication, knowledgeable about the latest and greatest best practices and endpoint data collection.
3. Familiarity with the latest oncology regulatory guidelines, especially for countries where your trial will be conducted.

Finding a partner with the right track record, scientific expertise and familiarity with the latest regulatory guidelines will put your trial in the best possible position for success.

Are they tech-savvy and operationally efficient?

Navigating the technological and operational demands in clinical trials requires a vendor who seamlessly combines technology and efficiency. Key aspects to consider include:

1. Their incorporation of new technology tools, including AI and machine learning, into their processes to ensure data integrity, privacy, and compliance.
2. Is there comprehensive 24/7 support across global time zones?  Their global scale can significantly impact on your ability to execute your trial locally.
3. Do they have efficient strategies in place to minimize change orders during the trial duration?

A background in new technology and a focus on operational efficiency at a global scale can help ensure your trial doesn’t run into difficulties.

How advanced are their eCOA and connected devices strategies?

When assessing the depth and innovation of a vendor’s strategies in eCOA and connected devices, it’s important to know their stance in the following areas:

1. Since regulators are increasingly asking for COA in trial submissions, what recommendations do they have for paper vs. electronic data collection?
2. What is their expertise in using Patient-Reported Outcomes (PROs) in clinical trials in that specific therapeutic area?
3. Is there availability and integration of connected devices to reduce participant burden and enhance Quality of Life (QoL) data collection?

A strong eCOA and connected devices strategy can improve data integrity, help increase patient retention and compliance, and reduce exclusion criteria.

How do they measure cardiac safety?

Since all drugs pass through the heart, cardiac safety expertise is crucial in clinical trials. To better understand their experience and methodologies, vital questions include:

1. Do they have experience in implementing strategies compliant with ICH E14 QT requirements?
2. What is their proficiency in blood pressure assessment best practices in clinical trials?
3. What is their approach to collecting ECGs, especially for patients with advanced diseases and multiple health conditions?

Choosing a core lab that follows cardiac safety best practices is pivotal to ensure the trial’s integrity and participant safety.

The complex challenges that clinical trials present necessitate a partner that is proficient in all these areas but also flexible enough to adapt quickly to sudden changes. This is not an easy task, and it requires due diligence to find the right partner that brings both robust expertise and tailored support throughout every trial phase. By asking strategic questions to your sales rep, you can better gauge the operational, technological, and scientific capabilities, to select a partner that serves as an extension of your team while paving the way for a trial that is meticulously managed and expertly executed.