The QP process is a necessary process that every sponsor company wishing to undertake trials in, or move product through the European Union must undergo. When faced with this process, many companies are unsure as to what to expect.
See how your colleagues in the drug development industry could surmise our participants’ aggregate answers from a survey of aimed at gaining an understanding of patient mindset and design more effective recruitment strategies.
Before the protocol authoring process even begins, a variety of activities and decisions are necessary to establish a strategy for success. The following steps provide concepts and considerations that are essential in formulating the details that will become the protocol synopsis and ultimately the clinical study protocol.
Sue Mann, Managing Director and QP Consultant of Sue Mann Consultancy answers your questions regarding the QP process.
This article discusses ways to adopt patient-centered drug development, changing the corporate culture and trial design, understanding patient needs and incorporating them into trials, and leveraging technology to conduct remote patient-centric clinical trials.
This case study details how Sherpa Clinical Packaging partnered with South Bay Therapeutics to craft the best clinical supply management strategies for their multiple, complex clinical trials.
To ensure the timely delivery of the necessary supplies, a sponsor must have a strong clinical packaging strategy that takes into account the most important details of its clinical study design. The goal is to be able to respond appropriately to any surprises or issues that could not only jeopardize your study but also potentially delay your product’s development and launch.
It’s important to take advantage of a slow-down in activities to plan for the future. Use any downtime during summer to plan ahead for your patient enrollment push in September and into the following year.
This is the first in a series of posts to help you navigate some of the roadblocks that may impede your ability to enroll patients during the summer months.
If your recruitment campaign includes advertising, digital and social media should be a part of it. Sponsors are increasingly turning to platforms like Facebook and Twitter as a way to target potential patients, especially because of the flexibility they offer.
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