March 1, 2023
The advent of outsourcing in clinical research came about in the 1980s based on transactional business-to-business interactions, which focused on the completion of specific development tasks. Through the 1990s, sponsors required a more sophisticated offering from CROs who were required to master fundamental study operations and processes, offering scalability to sponsors’ operations departments. As innovative science targeted more nuanced patient populations in the 2000s, CROs were required to anticipate a sponsor’s needs, forming sponsor-CRO relationships which would evolve into true “partnerships” in the next decade. Today, we see the need for innovative and strategically focused CROs that appreciate the value of the sponsor’s assets and can guide the optimal development route, integrating science and methodology with regulatory affairs and operational excellence. These new partnerships transcend traditional commercial relationships, which limit the ability of a CRO to add value to a development program. Instead, a CRO offering consultative services and strategic development elevates the full development program. The Benefits of Early Engagement The most successful sponsor-CRO partnerships begin with early engagement during the outsourcing process, which enables a more systematic and thorough evaluation by the sponsor and allows the CRO to develop the optimal operational strategy. From those early conversations, the engaged CRO members can ensure the goals and assumptions of the sponsor are integrated into the proposals and planning activities...
June 15, 2022
By: Aman Khera, VP, Global Head of Regulatory Strategy The industry moved at 1,000-miles-per-hour to implement digital solutions during the pandemic. Now, it’s time to pull back a little. We need to create a framework around the use of digital technologies in clinical research. Regulatory agencies must lead the way with clear direction. At the same time, they must also work together with industry to ensure that the path we follow gives patients the data transparency and ownership they so urgently crave. We must move forward thoughtfully, with the same rigor expected in clinical trials. While great digital tools exist to open data access and make studies more convenient, restoring patient trust requires more than merely transitioning from paper-based forms and processes (e.g., consent forms) to digital ones. Although certainly beneficial, I’d argue such tools don’t represent real innovation. Real innovation entails viewing digital technologies through the eyes of the patient, setting frameworks that break down silos in ways that ultimately offer transparency and put patients in control. Others have also noticed “… a growing emphasis on the ethical, responsible and transparent use of AI and data science.” But as one author notes, “In order for the promise of digital health to be realized, companies will need to ensure their patients’ data is safe, secure and error-free.” That’s where...
June 7, 2022
In her own words, a daughter shares how a career in cancer research helped support her mother’s courageous battle with late-stage ovarian cancer. By Cathy Purvis, MBA; Site Activation Manager, Oncology and Rare Disease, Worldwide Clinical Trials I landed in oncology thanks to the luck of the draw. This area happened to be where I was assigned when first starting in Site Activation. I quickly became intrigued by the complex nature of the study/site processes and did whatever I could to meet and beat targets, despite the additional oversight that often accompanies oncology trials. I also enjoyed building relationships with both the sites and sponsors, as I mainly was working with small biotech companies on Phase I escalation/expansion trials. In January 2020, my mom had not been feeling well and decided to go to the doctor before attending my twin nieces’ first birthday party, thinking her symptoms, including a rash on her abdomen, might be shingles and didn’t want to expose them. Well, it wasn’t shingles – it was late-stage ovarian cancer. She quickly got in to see an oncologist and on a treatment plan. After several rounds of platinum chemo, plus a surgery, she was considered cancer free. However, her three-month scan showed the cancer was back and even more aggressive than before, and she was indicated as platinum-resistant....
May 31, 2022
By: Kerri Padgett, Courageous Parents Network This year, I will celebrate the life of my son, Kai, for the 10th time since his passing from hypothalamic optic glioma at the age of two. I feel immense gratitude for the support we received during his cancer journey, but there are also moments when I wish I’d had more support. I know there are many families out there needing more, too. I am sharing our story during Brain Cancer Awareness month to offer opportunities to consider an improved experience for families facing one of the hardest things life can bring. Kai received a formal brain tumor diagnosis at eight months of age, after I spent months working to convince doctors that he was regressing at a concerning rate and something was wrong. During this time, we saw over a dozen pediatricians, neurologists, and ophthalmologists trained to find the most probable cause of his symptoms. This practice makes sense in theory, but for Kai, this meant our journey to diagnosis was long, as the “most likely answer” never quite fit. The diagnosis was equal parts devastation and relief – relief after months of trying to figure out what was wrong, and devastation to know Kai had cancer. But, it was the first step towards helping my baby feel better. Though I faced many...
May 20, 2022
The past few years we’ve had exciting opportunities to work on more cell and gene therapy programs for our sponsors. The industry is just at the tip of the iceberg for exploring the potential of these therapies in revolutionizing how we treat disease, and as the approvals start to trickle in, the pipeline only grows. (For a full look at the cell and gene therapy landscape, check out our webinar titled: “Changing Times, Changing Therapies: Keeping Up with Advancements in Cell and Gene Therapy.”) Right now, the pipeline is booming—since 2012, there has been a 10x increase in gene therapy development, up from nearly 200 to more than 2,000 today, according to the American Society of Cell + Gene Therapy. Most of the pipeline is for anticancer therapies and therapies for rare cancers1. Since these therapies go beyond symptom management to address the cause of the disease, the treatment potential surpasses what most previous treatments could offer to patients. Even the most devastating of rare diseases could be offered the possibility of treatment in the next few decades. Most treatments currently in development are in the early stages, with around 70% still in preclinical and only 1.4% (26) currently in Phase III of their program1. Though some of the disparity can be attributed to the difficulty of advanced therapeutic development,...
May 19, 2022
At Worldwide Clinical Trials, we are passionate about the work we do every day and its impact on countless patients and their families around the world. For International Clinical Trials Day 2022, take a moment to learn more about what it means to be part of a Contract Research Organization (CRO) – and how you can join our global team of experts. We have opportunities for all types of professionals from various industries and backgrounds. Learn more here.
April 21, 2022
In our latest employee spotlight Q&A, Hana Smoljanovic shares her experience as a Franchise Lead in clinical operations site management for Worldwide Clinical Trials. She discusses her personal and professional motivations, and what she believes best sets Worldwide apart from other CROs – our people. Q: Thank you for speaking with us today, Hana. Why did you first apply for a role with Worldwide? At the time, I was working at a local CRO as a CRA outsourced to a global sponsor. A colleague I studied with, who was working at Worldwide, contacted me to see if I was interested in joining the company. But since I had just had a baby and I was not interested in a change at that time. My colleague was persistent, however, so I finally accepted an interview. The person who interviewed me thrilled me with her professional approach. She presented the company to me, the expectations of the role, and the professional development opportunities available at Worldwide. In the first few minutes, it became clear that we could achieve productive cooperation and that I would have plenty of opportunities to develop as a professional. In 2009, I joined Worldwide as a senior CRA. Q: What makes Worldwide stand out from other CROs? Satisfaction at work is much more than a salary; it’s a...
By Dave Bowser, Chief Operating Officer,
November 10, 2021
I look back on my days as a Captain in the United States Marine Corps, and the skills I learned have driven my career success in healthcare, first working at Pfizer running drug development programs, and now at Worldwide Clinical Trials leading clinical research to bring drugs to market. There are three things that I attribute to my success and, this Veteran’s Day, I’m asking military veterans to join me in improving patients’ lives at Worldwide Clinical Trials. Exceptional project management skills Clinical trials are complex, so it is essential to have exceptional project management skills to ensure that trials are set up, enrolled, conducted, and reported on time and on budget. Military veterans typically possess this ability. The project management skills I used as a combat engineer to build bridges, roads, and explosives gave me the discipline that has been a common thread throughout my career. Commitment to a cause bigger than themselves Along with discipline and project management talent, military veterans have the commitment to a cause bigger than themselves. People at Worldwide care about the patients and want to see drugs get to market that can improve patients’ lives and drive healthcare forward. Along with this commitment comes the dedication and work ethic to spend the time. It’s easy to have a work ethic when you believe...