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Sep 16 2015

The New Clinical Data Manager

Cortney Greenhalge, CDM, PROMETRIKA, LLC

The role and skill set of a Clinical Data Manager (CDM) is constantly changing as technology and processes advance. CDMs have evolved into data management leaders, possessing skills in areas such as database building and programming, project management, and budget maintenance, on top of the standard collection, cleaning, and management of subject data in compliance with regulatory standards. With the addition of new regulations and electronic data capture (EDC) systems, more and more data managers are “wearing multiple hats.” The need for well-rounded, informed, and cross-functional CDMs is on the rise. How do we ensure that we, as CDMs, keep pace with the significant technologic advances that have occurred within clinical research over the last 10 to 15 years? Continue reading “The New Clinical Data Manager”

Aug 19 2015

Risk-Based Monitoring

by Kara Grew, Clinical Operations Project Manager

Risk-based monitoring in clinical trials involves targeted monitoring that may include 100% source data verification for specified critical data points and partial source data verification of other data. In most cases, the risks of the trial and the data to be collected are determined prior to study and site initiation, to identify monitoring needs. In addition, a Medical Monitor or Clinical Director will often provide input into the identification of critical data points based on the therapeutic area, indication, overall protocol requirements, safety profile of the compound, device or biologic,  and the primary and secondary endpoints for evaluation. Once the plan for targeted monitoring is finalized by the study team, the Risk-based Monitoring Plan will be included as part of the overall Monitoring Plan and Clinical Research Associates (CRAs) assigned to the trial will be trained on these monitoring requirements.

Continue reading “Risk-Based Monitoring”

Jul 14 2015

Ensuring the IDMC is Independent: The Case for Outsourcing IDMC Statistical and Coordination Services

Amanda Rychel

The number of clinical trials incorporating independent data monitoring committees (IDMCs) for safety and efficacy monitoring is on the rise. Currently, it is recommended that late-stage trials with a major morbidity or mortality endpoint, or studies in vulnerable patient populations with a large enrollment, use an IDMC to review the interim safety and efficacy data. By definition, an IDMC is an entity that operates independent of the study sponsor. To limit bias, it is important that the sponsor is able to manage the trial while an independent body makes decisions on the safety and therapeutic values of continuing the trial. Continue reading “Ensuring the IDMC is Independent: The Case for Outsourcing IDMC Statistical and Coordination Services”

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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