PROMETRIKA, LLC

A Full-Service Clinical Research Organization

Jun 03 2015

A New Certification to Come to Clinical Research

M. Alexandra Rohall, Sr. Manager, Medical Writing, PROMETRIKA LLC

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Many clinical research professionals can add a string of letters after their signatures, such as CCDM (Certified Clinical Data Manager), to show that they have obtained certification in their profession. Certification is issued by an accrediting body (such as the Society for Clinical Data Management) to those who pass a comprehensive examination. Certification is recognized throughout the clinical research field as a sign of professional competency and knowledge of clinical development in the pharmaceutical industry. Continue reading “A New Certification to Come to Clinical Research”

May 14 2015

Keys to Effective Clinical Trial Site Management

Kara Grew, Clinical Operations Project Manager

Proper site management by the Sponsor and/or CRO is an essential element of clinical trial execution and in ensuring trial success. An appropriate level of site management and oversight empowers sites to effectively recruit, treat, and retain subjects while ensuring regulatory compliance, protocol adherence, the protection of subjects’ rights, subject safety, and overall management of screened and enrolled subjects. Continue reading “Keys to Effective Clinical Trial Site Management”

Apr 24 2015

PROMETRIKA Guides Mindful Implementation of ePRO Solutions

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Patient Focus

Today’s clinical development is more patient-centric – focusing not only on treating the patient’s disease or dysfunction but also on the patient’s experience of, and desired outcomes for, treatment. Sponsors must make mindful decisions as they select new technologies to directly collect data from patients and use it in statistical analyses. Multiple parties are involved in the decision around collecting patient-reported outcomes (PROs), one of the four forms of clinical outcomes assessment (COA). Drug and device development sponsors, sites, CROs, patients, and even patients’ families have roles in determining what PRO tools are best suited to a particular study. PROMETRIKA’s data management experts have eased sponsors’ entries into the effective use of ePRO tools in today’s electronic data environment. Continue reading “PROMETRIKA Guides Mindful Implementation of ePRO Solutions”

Apr 17 2015

PROMETRIKA Supports Advanced Research in MS

Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating disease of the central nervous system (CNS). It is hypothesized that CNS auto-reactive T cells are stimulated in the peripheral circulation to become active and proliferate, with subsequent migration into the CNS compartment. These cells, upon interacting with CNS myelin antigens, again proliferate and initiate a pro-inflammatory cascade within the brain that results in damage. Continue reading “PROMETRIKA Supports Advanced Research in MS”

Mar 11 2015

PROs: Ground to Cloud in 10 Years

M. Alexandra Rohall, Sr. Manager, Medical Writing, PROMETRIKA LLC

Patient-reported outcome (PRO) instruments, such as patient-completed (or interviewer-administered) diaries, questionnaires, and visual analog scales (VAS), have been a part of clinical research for many years. The sponsor’s objective in using PRO instruments is to measure the clinical effects of treatment, especially for parameters that are difficult to measure objectively, like pain. Continue reading “PROs: Ground to Cloud in 10 Years”

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