Virtual trials are growing in acceptance. The patient-centric aspect of these trials makes them easier to recruit and retain patients and accelerate timelines, while also providing patient data to researchers in real time. But will virtual trials also mean the end of CROs?
DIA’s Inspire Awards have grown every year that Barbara Lopez Kunz, global chief executive for DIA, has been with the organization. Kunz, who has been with DIA since 2013, notes it has become the place to be for attendees travelling to the annual meeting.
You just wrapped up a productive meeting with the FDA. The FDA reviewer has agreed to your clinical strategy. Your leadership team is excited and cannot wait to launch the clinical trial.
Having a highly-qualified clinical site participating in a trial can be a blessing to any operations person. Sites interact with patients, help pharma test new therapies, and provide reliable data that leads to regulatory approval. When evaluating sites, how can you tell which ones will over-perform and which will leave you wishing you had passed on them altogether?
Over the last 10 years, the face of clinical research & development (R&D) and pharmacovigilance (PV) outsourcing has dramatically changed. What was a common industry scenario by 2010 — a full-scale operational pharma company utilizing both international and U.S.-based contract research organizations (CROs) to execute clinical investigator site monitoring and data management — has evolved into a new common scenario in 2019.
As the Otsuka VP of Applied Innovation and Process Improvement, Debbie Profit spends a lot of her time thinking about the future of clinical trials. “There are changes occurring in the industry that will force clinical development executives to shift their mindset,” says Profit. “I am trying to understand what clinical trial sites will look like going forward.”
ArQule is a personalized medicine company working in the oncology space to develop treatments that target specific mutations. While attempting to overcome a challenge with its product, ArQule was approached by a group at the NIH which wanted to partner to help patients with an ultra-rare disease known as Proteus syndrome.
When preparing for a large Phase 3 trial, many small companies may need a Big Pharma partner to help them through the process. But how do you connect with large companies? And what are the best practices for working with them? A panel at the 2018 Clinical Leader Forum in Philadelphia attempted to bring some clarity to those questions.
On March 1, 2018, the Partners in Innovation, Education, and Research Consortium™ (PIER) became an LLC in the State of Delaware. The six founding members of PIER (Jefferson Health, Atlantic Health System, Drexel University, Einstein Healthcare Network, Geisinger Health System, and Main Line Health) hope to bring efficiencies and cost reductions to clinical research.
This is the third article in a series examining strategies that allow quality groups to collaborate with good clinical practice (GCP) and good manufacturing practice (GMP) divisions to improve compliance, increase clinical study robustness, and enhance data integrity.
|
|
|
|
|
|
|
|
|