What changes can you expect to see in clinical trials going into 2016? George Betts, Senior Director of Medical and Regulatory Affairs for Ipsen Biopharmaceuticals, believes patient recruitment and technology will continue to be a focus for sponsors going forward. He also believes that the specialty CRO market place will continue to grow as many sponsors move away from strategic partnering and go back to FSP relationships with smaller, specialty CROs.
Clinical research is transforming from a paper-driven model into one that is almost wholly electronic. This goes well beyond the electronic transcribing of data. Wearables and smart phone technology now make it possible to electronically collect data directly from clinical research trial participants, skipping many manual and middle steps.
Precision dosing―the right dose, for the right patient, at the right time―is crucial to providing patients with the safest and most effective medications. To make the dream of precision dosing a reality requires new approaches in drug development.
Human Biological Samples (HBS) are collected during a biopsy or surgery to diagnose the patient and are preserved for later use by researchers to study the disease progression to bring about potential benefits to the patient community. Despite the varying regulations, HBS collection and biobanking has evolved throughout the years. This whitepaper discusses the trends, supplier landscape, and segmentation by providing visibility to the HBS market and the benefits of engaging with a commercial vs. public biobank.
As per GCP, “If it is not documented, it is not done”. So, documentation is a vital part of the clinical trial process. Moreover, considering the complexities of managing clinical trials because of the involvement of different stakeholders and vendors, maintaining proper documentation is always a challenge.
Simple miscommunications or clerical errors can be the difference between the success and failure of a clinical trial. However, many clinics and labs are still tracking their sample inventory on spreadsheets as they did 10 years ago. This method may be adequate for small labs with a close team, but it proves ineffective in multi-center clinical trials.
If the method used to determine whether or not a protein is a viable target for drug development were improved, pharmaceutical companies could potentially avoid the losses associated with finding out too late that a drug has harmful side effects and/or a lack efficacy. So how can pharma do this? Well, fortunately for them, some new technologies are now available to enhance their ability to select and evaluate safer targets in improved cell systems.
Patients have become more empowered, better informed, and more financially invested in their health and well-being than ever before. As a result, we have seen the healthcare landscape evolve toward a patient-centric delivery model.
Everyone has experienced poor customer service in one form or another. Say you want to call a company with a question or a complaint about a product. You’re likely to be informed by an automated voice that, “Due to the high volume of calls we are currently experiencing, your anticipated wait time will be X minutes. For faster and more convenient customer service, please visit our website at www.wedon’tcaretospeaktoyou.com.
Last week, Matthew Herper of Forbes published an eye-opening article providing a closer look at FDA approvals in recent years, coming to the conclusion that the industry is facing what could be a dangerously high approval rate for new drugs. But how could high approval rates be a bad thing?
Shortly after the April 2015 publication of Guiding Bayer’s Global Innovation Engines To New Heights, an article I wrote featuring Bayer board of management member, Kemal Malik, I received a phone call from Valerie Bowling. The executive director for the Conference Forum and producer of one of my favorite events, Disruptive Innovations to Advance Clinical Trials (DPharm), Bowling said the article sparked an idea.
Being able to keep track of your clinical trials in real time is vital to your study’s success. TrialManager® allows you to do just this.
Full capability is the approach inVentiv Health takes to bioanalytical development regardless of your project size. Through our GLP-compliant laboratories, an extensive list of validated assays, custom assay services, knowledgeable scientists, and skilled technicians, inVentiv Health Clinical provides bioanalytical services in all stages of drug development.
In addtion to our core therapeutic areas – CNS, Cardiovascular, Chronic Inflammatory Disorders and Oncology – Worldwide Clinical Trials is pleased to offer sponsors exemplary service and expertise in other key treatment areas: Respiratory Disorders and Orphan Indications.
As a full-service CRO, our capabilities span all phases of clinical development. Our project teams are created based on client and project needs and provide therapeutic expertise at all levels. We partner with clients across all areas of the clinical program, from protocol development to regulatory submission and this facilitates achieving the highest level of quality and efficiency in our work.
TrialMax Touch™ is a handheld diary that can be used by patients at home or by the caregiver. TrialMax is a software platform that provides a single solution for eCOA (electronic Clinical Outcome Assessments) in Phase I to IV clinical trials.
Advancements in assessing cardiovascular safety and a changing regulatory landscape pose challenges for clinical trial sponsors seeking drug approvals. You rely on a cardiovascular service provider with the experience to support a wide range of centralized assessments and the expertise to implement successful safety and efficacy programs. BioClinica operates the world’s largest and most experienced imaging core lab combined with comprehensive cardiovascular safety services, providing clinical trial sponsors with the scientific And regulatory expertise and technology required to run high quality, cost effective cardiac safety studies.
Our TrialStudio® tool enables us to design and adapt eCOA questionnaires quickly, saving you set-up time by leveraging re-use of instruments and diary components.
Welcome to Clinical Leader, the premier online community that helps streamline clinical research by connecting trial sponsors and cutting edge service providers. Clinical Leader is part of the Life Science Connect media group. The vision of Life Science Leader and Life Science Connect is to help facilitate connections and foster collaborations in pharmaceutical and medical device development to find ways to get more life-saving and life-improving therapies to market. Connect, Collaborate, Contribute.
Visitors are enriched with valuable information on CRO, Pre-Clinical Contract Research Organization, Bio-Analytical Contract Research Organization, Clinical Contract Research Organization, Pharmacovigilance, Clinical Data Management, Electronic Patient Reported Outcomes (ePRO), Point-of-Care Testing (POCT), Patient Recruitment, Electronic Data Capture (EDC), Clinical Trials Management Systems (CTMS) and more that can improve your business and make it more profitable.
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Watch the webinar now to learn how an innovative approach can improve the clinical trial experience and move medicine forward.
Interest in using electronic patient reported outcomes (ePRO) on smart devices is on the rise. In this webinar, Emily Cantrell and Becky Baggett will share lessons learned working on a large phase 3 pain study that utilizes ePRO on tablet devices.
This webinar will discuss some of the benefits of an eSource approach, which include eliminating double entry of data and the need for source data verification, reducing the need for data queries, and optimizing monitoring time.
How People, Process and Tools can Improve Clinical Trial Quality