Spaulding Clinical Research Awarded Five-Year Contract With FDA

West Bend, Wis., February 27, 2020Spaulding Clinical Research today announced that it has been awarded a five-year contract with the U.S. Food and Drug Administration (FDA) Division of Applied Regulatory Science to conduct multiple clinical trials in various therapeutic areas of interest. They have kicked off this agreement with $5 million of clinical trial work to be run in 2020. Spaulding Clinical is responsible for conducting the trials and providing the necessary support services including clinical trial recruitment, conduct, and laboratory assessments.

The objectives of each trial vary considerably among different therapeutic areas, but all address important regulatory science questions in today’s pharmaceutical market.

“We are happy to partner with the FDA to help address agency questions about various classes of drugs. Spaulding Clinical is perfectly suited to conduct these trials as we have the right-sized project management and principal investigator team that will be able to give the FDA office the attention they need,” said Cassandra Erato, CEO at Spaulding Clinical Research.

Spaulding Clinical has been working with the U.S. government on clinical trials over the past seven years. “We began conducting clinical trials for the FDA to explore a model to screen new drugs for prolongation of QT. Through this work and resulting publications, we have developed a productive partnership,” said Dr. Jay Mason, chief medical officer at Spaulding Clinical Research.

About Spaulding Clinical Research

Spaulding Clinical opened in 2008 and was built upon fully electronic data and integrated, purposefully engineered systems for conducting Phase 1 trials. Spaulding runs a 200-bed facility in West Bend, Wisconsin, and conducts and analyzes First-in-Human, clinical Proof-of-Concept, cardiovascular safety (TQT, concentration effect), and NDA-enabling clinical pharmacology studies. Spaulding Clinical provides expertise on study design, medical writing, clinical data management, biostatistics, and PK/PD analysis. Learn more at spauldingclinical.com.

6 Top Factors to Look for In Phase 1 Provider

Phase I is not just an obstacle you need to get through. Phase I clinical trials are an integral step in the drug development process and choosing the right Contract Research Organization (CRO) is crucial to its success. With so many CROs to choose from and the focus on getting to the next step of the process fast, the importance of finding theright partner for your Phase I study can get overlooked. As a pharmaceutical executive with more than 10 years of experience in clinical research operations, I encourage you to consider the vital importance of this relationship and select CRO partners that will set the course for development based on the following criteria:

Size

When selecting a CRO partner, bigger is not always better. Due to their size and areas of specialization, smaller CROs are often superior partners for early stage research. While larger providers may have the global footprint and existing infrastructure required to conduct large-scale studies, they typically lack the flexibility, personal service, and senior management involvement provided by specialized CROs. Additionally, such smaller, specialized CROs are typically able to assemble high-level team members with the right experience to fit the specific requirements of a study and scale services up or down as needed. Larger CROs can get bogged down by processes, resulting in slower response times.

Specialization

Choosing a CRO that meets your specific needs can make all the difference in your outcome – while a full-service, unspecialized CRO may have the capacity to perform the services you need, why not consider one that is specialized to do so? At Spaulding, we laser-focus our efforts on Phase I. It’s what we know best — so it’s what we do best. And our passion and dedication to Phase I makes a big difference when you want to move trials forward on a reasonable timeline.

Cardiac safety experience is a big deal in Phase I. Navigating the E14 guidance can be overwhelming when running your first human trials. You can increase the value of your product and avoid surprises later on by strategically placing electrocardiograph evaluations in your first trials early on. This does not have to be expensive, but it does require the right expertise to evaluate your preclinical data to make the right recommendation. Many CROs will bring in an expensive consultant to advise you on this. Spaulding Clinical was founded on cardiac safety — it is a part of who we are — and our experts are available in every conversation.

Fast Results

Speaking of timelines, in our industry, timing is everything. Anything that delays the process can compromisethe entire timeline. For example, we’re very proud of our ability to deliver quality data faster than industry average:

  • eSource build and first subject screened in four weeks (industry average is eight to 12 weeks); while much of our competition is new to eSource, we have been paperless and fully integrated for more than 12 years
  • Flash report including essential data to make faster go/no-go decisions provided as fast as seven days
  • Final CSR in 45 days (industry average is about 100 days)

What does that mean for you? It means you can make decisions faster and spend less on overhead while waiting for results.

eSource Solutions

It’s hard to believe many Phase I sites are still collecting data on paper. This leads to more money spent on data cleaning, more clinical monitoring, and even poor-quality data as this method is prone to human error. Electronic data capture reduces error and supports faster results. It is also important to ask your CRO partner how recently they have implemented eSource. It can take 1-2 years for a CRO to become fluent in eSource.

Spaulding Clinical has been fully paperless using electronic data capture for 12 years. This kind of experience exponentiates the value we provide. You end up working with a team that is an expert in eSource rather than a team that is still learning it — while they’re working on your study.

Experience

When evaluating CROs, start by assessing their experience and take time to understand their clients and teams. An organization with a solid track record of providing services from protocol design to final study reporting can help shorten timelines for quicker decisions and ultimately save you money — two factors that are extremely crucial for fast-paced Phase I trials.

Again, a CRO like Spaulding Clinical, which has experience with Phase I clinical trials and cardiac care, can help you stay on track while providing the most accurate and timely assessments of cardiac risk in the early stages of drug development. And that’s experience you can trust.

Customer Service

As regulatory requirements evolve and your data submission deadlines grow shorter, your need for a partner that’s truly committed to your deliverables is critical to success. A good CRO partner will provide a flexible and adaptable approach to deal with bumps in the road as well as help guide next steps for smooth and efficient processes. When selecting your CRO, look for a candidate that can tailor its offerings based on your discovery program’s needs. After all, your project is your top priority. You deserve a CRO that’s going to give it significant attention, not a company that’s going to prioritize larger clients over you. If you find you’re not getting the attention you need, consider switching to a CRO with better service.

Putting It to Work for Your Project

Proven experience, capabilities, and service should be top of mind when selecting a CRO partner for your Phase I trials. It can be easy to continue to assign new projects to existing CROs based on previous results or established relationships. However, it’s important to explore all your options and find the partner that’s truly the most qualified for the job.

About Spaulding Clinical

A full-service, state-of-the-art Phase I clinical testing facility, Spaulding Clinical specializes in cardiac safety testing and provides the highest quality data to not only save biopharmaceutical clients time and money, but also uncover risks early in drug development. From our cardiologists to our highly trained nurses and research staff, every employee is focused and committed to ensuring clean, high quality data for Phase I trials and beyond. To learn more, visit spauldingclinical.com.

Spaulding Clinical Announces COO Cassandra Erato Will Succeed Randy Spaulding as CEO

WEST BEND, Wis.(February 6, 2020) – Spaulding Clinical Research announced today that it has named Cassandra Erato chief executive officer, effective February 1, 2020. Randy Spaulding will assume the role of founder, chairman, and chief visionary officer.

“I am honored to assume leadership of Spaulding Clinical. Mr. Spaulding built our Phase 1 site based on the vision of building the first fully paperless Phase 1 CRO and a world-class cardiac safety testing site,” said Erato. “He was clearly 10 years ahead of his time, as we’ve seen other Phase 1 units start to adopt eSource solutions in the past year. He has introduced many new functionalities and integrations; recently, he introduced a new functionality that allows us to deliver flash results faster than anyone in the industry. I am committed to continuing to grow Spaulding Clinical and build upon the excellent foundation that has been laid.”

Randy Spaulding will continue an active role as managing member and will focus on the next innovations of the company.

“Our vision is to continue to deliver new technologies that enable our customers to make decisions faster and bring new, life-enhancing drugs to market faster than before,” said Spaulding. “Mrs. Erato is the best person to execute on this vision and help us achieve our next phase of growth. This enables me to focus even more time on developing new technologies for the pharmaceutical development industry.”

Mrs. Erato is currently the COO of Spaulding Clinical and has held the position since 2015. She has been with Spaulding Clinical since its inception in 2007 and has played a key role in developing the operational procedures and systems in place today.

Erato will be attending SCOPE 2020 in Orlando, Florida, the week of February 17 and is available for interviews.