Changing the culture within a large company can be a difficult endeavour. That is certainly true when trying to make your company and your clinical trials more patient centric. Janssen is one of many pharma companies attempting to get the voice of patients more incorporated into product development and trial designs.
There is a growing industry focus on standard operating procedure (SOP) remediation. Although outsourcing, mergers, and acquisitions have been in play for the last 20 years, these activities seem to be skyrocketing, which is creating quite a few scenarios that drive the need for SOP remediation.
Qualified Persons (QPs) are responsible for the certification of clinical trial materials in the EU and therefore are an essential link in U.S. sponsors’ supply chains. Indeed, engaging QPs well before the clinical trial material needs to be certified not only assures a smooth release process and trial start-up but mitigates pitfalls associated with unanticipated technical, quality, and regulatory challenges.
While it is not a new trend, the spotlight on digital innovation has grown brighter over the last year, with executives from all sides of the clinical research industry seeking technology solutions to improve the clinical trial experience for sites and patients alike. It was a recurring theme at this year’s Society for Clinical Research Sites (SCRS) Global Site Solutions Summit, with several sessions that addressed technological advancement and attendee feedback requesting more discussion on the topic at future Summits.
Pharmaceutical companies and research institutions are feeling the pressure to reduce the time, financial, and other resource costs associated with conducting clinical trials. With the influx of emerging applications for technologies such as machine learning, robotics and automation, and blockchain and other distributed ledger technologies (DLTs), many see a new path to more efficient and effective processes that can address the challenges faced today.
For U.S. sponsors planning to conduct clinical trials in the EU, Qualified Persons (QPs) may at times be perceived as a challenge to overcome, because their role and responsibilities are not fully understood. Conversely, part of the QP’s role is to support clinical trials in the EU by certifying compliant clinical trial materials while protecting public health.
Health authority inspections are one of the most stress-inducing experiences a sponsor, CRO, or site will go through. The mere mention of inspections is enough to throw some people into full on panic-mode. While preparing for an inspection will never be a care- and stress-free process, there are appropriate ways to get your organization ready for one without adding another layer of stress and frustration.
In response to the increasing opacity of the trial master file (TMF), clinical trial decision makers have embraced quantitative metrics as a way of characterizing and understanding the health of a TMF. Quantitative metrics are easily generated through the reporting functionality of a modern electronic TMF (eTMF) and appear to add value by leveraging the data passively generated through modern clinical applications. Although helpful to address specific concerns, especially those related to completeness, these metrics are often unintuitive and do not readily describe the aspects of a clinical trial most instrumental for TMF health.
Historically, patient involvement has been vital in the design and execution of clinical trials, but in recent years there has been an increased desire to engage patients from start to finish during the drug development process. Today, patients are empowered by technological advances that have given them access to more information than ever before, especially regarding diseases and drug development.
IN 2018 there were many changes, trends, regulations and priorities that shaped the direction of the clinical research and drug development fields. In this paper, WCG experts share what they anticipate in 2019, and what everyone should be prepared for as we approach another year of change.
This paper looks at validation of Software-as-a-Service (SaaS) solutions and provides relevant points to consider when developing a risk-based approach to validation.
While adaptive design is associated with many potential benefits, it may also present challenges to observing the basic ethical principles of research in human subjects. In this white paper, we review the features of particular clinical trial design adaptations and discuss the ethical obstacles they can present and those they can potentially resolve. Using examples of both published and unpublished clinical studies, we highlight the importance of proper design and planning and appropriate ethical due diligence in the successful conduct of an adaptive design clinical trial.
It is up to pharmaceutical companies sponsoring clinical trials in the EU to have complete control of their supply chain. Understanding recent changes to the EU GDP guidelines can help achieve this as they now offer a more comprehensive guidance for temperature management during storage and transportation.
Whether you are conducting a phase 3 clinical trial of a new therapy or looking for biomarkers, you will need to collect samples, and that leads to a number of questions. Following are some basics to help with planning sample collection and to help make the process as cost-effective as possible.
Vendor-selection processes are tilting toward finding as broad and deep a fit as possible, the better to capture the efficiencies from scale and repeatability that those moves are intended to deliver.
Client turns to this CRO when they needed a team experienced with the full range of IDMC activities to provide a seamless solution.
Compromised data collection effectively stalled a clinical trial study of an inflammation control drug. With help from a CRO, important lessons were learned about the need for discipline and following protocol as well as the identification of Russia as a highly desirable site for clinical trials.
Best practices to ensure a successful sponsor-CRO collaboration
Ensuring your material is stored under appropriate conditions is only half the battle in preserving its integrity. Equally as critical is the precarious process of transporting your material to its destination, safely and in the same condition it was sent in. Maintaining the chain of custody is of utmost importance, and a large component of this is based on the vessel selected for transportation. In this article, we’ll share some key items to consider when selecting shippers to transport your high value material.
From a historical perspective, there are millions of FFPE tissue blocks in storage and in use today. Most storage process work well for small numbers of samples, but is quickly overrun when thousands of blocks begin to accumulate. A new end to end system has been developed and implemented in several locations worldwide to address the issues encountered with FFPE block storage, retrieval and restocking.
Engaging clinical supply management and forecasting adds value by evaluating different response strategies and contingency plans and can identify supply solutions that minimize or even potentially avoid supply chain disruptions.
Patient recruitment and retention continue to hamper clinical trials, causing delays in start up and forcing some studies to be cancelled altogether. Approximately 50 percent of trials have delays in recruitment, costing companies an estimated $600,000 per day. In this free collection of articles, our experts from pharma discuss the actions you can and should be taking to make trials more patient centric.
More Content CollectionsWhile it is not a new trend, the spotlight on digital innovation has grown brighter over the last year, with executives from all sides of the clinical research industry seeking technology solutions to improve the clinical trial experience for sites and patients alike. It was a recurring theme at this year’s Society for Clinical Research Sites (SCRS) Global Site Solutions Summit, with several sessions that addressed technological advancement and attendee feedback requesting more discussion on the topic at future Summits.
Historically, patient involvement has been vital in the design and execution of clinical trials, but in recent years there has been an increased desire to engage patients from start to finish during the drug development process. Today, patients are empowered by technological advances that have given them access to more information than ever before, especially regarding diseases and drug development.
Those who know me understand the value I put on bringing the voice of the patient and caregiver into the drug development process. They also know that I believe that today’s terminology — phrases like “patient-centricity,” “patient at the center,” and other sexy mottos — is sometimes used by organizations to show the world that the patient is at the forefront of everything they do. But are they really? Is patient feedback on a protocol enough to prove that their voices are heard? Is providing input on an informed consent what a patient really wants to do? Maybe.
