As the Chief Technology Officer (CTO) at ProofPilot, the industry's only platform for clinical trial automation, guidance, and knowledge management, I often find myself marveling at the intricate dance of data, systems, and regulations that underpin our platform. In this article, I'm excited to delve into how our platform orchestrates the entirety of the clinical trial process and the critical role that integrations play in achieving seamless operation. At ProofPilot, we understand that conducting successful clinical trials requires more than just collecting data. It requires a sophisticated ..read more

I am a pharmacist (and a female) working at a tech startup in life science. Here are 3 things I have learned about the tech startup space, as a transplant.  ..read more

In the dynamic realm of clinical research, basic adherence to the protocol stands as the definition of success. In our recent "Do You Even Science?" webinar, our expert panel delved into the big picture challenges of protocol compliance and the importance of embracing back-to-basics innovation to navigate this high stakes terrain. Let's recap the key takeaways from this insightful discussion, shedding light on the fundamental principles that not only drive, but define clinical research.  ..read more

Reflecting on SCOPE 2024, I'm filled with a sense of personal fulfillment and excitement for the future of clinical trials. The energy and passion exhibited by industry leaders and innovators were truly contagious, leaving an indelible mark on my professional journey. It's with great enthusiasm that I share the highlights of this remarkable event ..read more

Micah Lieberman and I  recently had a live chat on LinkedIn about getting the most out of the SCOPE Summit, which is a yearly conference for Clinical Operations professionals, attracting approximately 3500 attendees each year and covering a broad set of topics related to clinical research ..read more

I recently had the pleasure of participating in the Society for Clinical Research Sites (SCRS) conference, SCRS West. Engaging with peers, sharing insights, and wrestling with challenges – the conference was energetic and thought-provoking. Being part of these discussions, particularly the Global Impact Partners (GIP) meeting, it was clear there are still industry-wide problems plaguing the most fundamental capabilities in clinical operations. Fortunately, these problems resonate deeply with the work we’re championing here at ProofPilot.  ..read more

Clinical research requires an extensive amount of documentation: protocols, manuals, visit guides, consent forms, case report forms, and regulatory submissions. Historically, paper has been the primary medium for referencing, storing, and sharing these critical elements, and guiding researchers and patients in conduct and participation. Sadly, it also does a terrible job of helping sites and sponsors execute high-quality research. In the end, written documents are a poor medium to instruct and guide the execution of a protocol, as evidenced by all the homegrown solutions created by site to ma ..read more

Elevated Patient Engagement and Protocol Success through Next-Gen Solutions at ProofPilot  I attended this year's Festival of Biologics conference from March 20-22, 2023, where I discussed how our team at ProofPilot reshaped the landscape by tackling patient dropout and protocol deviations. According to the Center for Info & Study on Clinical Research Participation (CISCRP), a surprising 30% of all patients drop out due to confusion and the overwhelming burden placed on them. Clinical sites regularly struggled with complicated protocols and disjointed technology, compromising data qu ..read more

Clinical trials play a crucial role in advancing medical knowledge, but they can be demanding for human participants in terms of time, effort, and potential risks. To ensure that these participants are treated with respect and dignity, it is crucial for life science researchers to establish fair compensation and/or reimbursement policies. However, these policies are complex and can have ethical and legal implications. I recently took a LinkedIn poll that showed quite a bit of debate in payment versus reimbursement for patients, indicating a need for greater clarity and understanding of these ..read more

When it comes to clinical trials, oncology research is in a league of its own. Cancer is a complex disease with more than 100 different types, each presenting unique challenges. Adding to that, patients with cancer often have comorbidities, which can make it more difficult to enroll them in trials. In fact, a study published in JAMA Oncology found that cancer patients were more likely to have at least one comorbidity than patients without cancer. Oncology clinical trials have also been shown to have the highest relative mean number of protocol deviations affecting more than 40% of patients en ..read more