Pain trials are uniquely challenging because they rely so heavily on patients’ own assessments. While researchers will always need to account for the placebo effect when studying indications as subjective as neuropathic pain, there are ways to increase the likelihood of achieving objective trial outcomes.
Any capable CRO can provide manpower and execute orders on behalf of a sponsor, no questions asked, with little stake or interest in the endeavor’s ultimate success. What you need is a strategic ally, a company that joins you, lockstep, in pursuing shared goals and greater outcomes. Not a vendor, but a partner.
The optimal dose-finding strategy for a given therapeutic agent and indication is based on a multitude of factors, accentuating the need for individual tailoring in oncology drug trial design. Read on for a look at six of the most common dose-finding trial designs in oncology today.
Mark P. Wade, Executive Director, Life Sciences at TransPerfect shares his thoughts on the ISOQOL 25th Annual Conference in Dublin. Hear what professionals that live and breathe Clinical Outcome Assessment (COA) measures learned from this event.
Recent scandals surrounding Chinese drug manufacturers have Chinese nationals looking outward, and have even sparked regulatory reforms. This lost faith in local drug companies begs the question: what does this mean for foreign investors?
These recent events stressed the importance of the use of an electronic content management system and striving for a paperless environment. Read key take-aways from attendees at these events regarding what the future of TMF could look like.
The translation process for clinical trials, regulatory affairs, and other high-risk pharmaceutical documentation is historically manual and time-consuming. Learn how companies can transform the translation process using technology and artificial intelligence to work more efficiently and get drugs to market faster.
Patient-centricity has been a growing trend across the pharmaceutical and biotech industries for some time now. As the focus on precision and personalized medicine continues to increase, sponsors are looking for innovative ways to increase patient enrollment and compliance while reducing drug development timelines and costs. The direct-to-patient (DTP) model has emerged as a potential solution. This model illustrates a means by which a patient is able to receive his or her medication in the convenience of their home. In this article, we’ll share the top three challenges many sponsors face, and how a direct-to-patient pharmacy can provide solutions.
The medical device industry is undergoing seismic regulatory shifts. These shifts have major implications for clinical trials and eClinical technology, and are largely aimed toward modernizing some of the industry’s biggest institutions – namely, the 510(k) program. At Medrio, we’ve been keeping close watch on how the story develops.
The process of formalin-fixed paraffin-embedding (FFPE) emerged in the late 19th century as a valuable histological method for stabilizing and preserving the morphology and cellular details of tissue samples. In 2017 the human tissues segment was estimated to account for the second largest share of the global biobanking market by sample type. This is attributable in large part to the expanded use of these tissues as molecular biomarkers of disease, primarily in oncology, using immunohistochemical and genetic-based assay systems.
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