Product and Services Finder

Clinical Trial Monitoring

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Bio-Optronics Inc.  Bio-Optronics is a leading provider of healthcare software and services including Clinical Trial Management Systems (CTMS) and Physician and Staff Scheduling for research organizations, hospitals and specialty practices...
Clinical Conductor CTMS The leading collaborative CTMS for research organizations looking to raise the bar in clinical research
Myriad RBM, Inc.  Myriad RBM is a CLIA-certified biomarker testing laboratory specializing in cost-effective, high-quality multiplexing services. Our protein immunoassays benefit drug discovery & development from preclinical through Phase...
Services Provided Myriad RBM, Inc. is the world’s leading multiplexed immunoassay testing laboratory, providing comprehensive protein biomarker services based on its...
MedNet Solutions  MedNet Solutions provides web-based eClinical solutions - electronic data capture (EDC), clinical trial management (CTMS), and investigator initiated trial (IIT) managment systems - for pharmaceutical, medical device and...
iMedNet EDC - MedNet’s innovative, SaaS-based eClinical solution that allows you to quickly, easily, and affordably configure your own studies.
CRR, Inc  CRR, Inc. has been providing clinical trial monitoring support to pharmaceutical development organizations since 1997. Our philosophy is to provide quality monitoring support with personnel with both clinical and...
Clinical List America  Clinical List America, formerly City List America, was started in 1993. We have a nationwide, proprietary medical database that is verified as 100 percent HIPAA compliant.
Clinical Trials Marketing Don't spend your time in patient recruitment, instead of that use the proven patient recruitment technique from Clinical List America to inflate the...
CLINICAL RESEARCH CONSULTING, INC.  Clinical Research Consulting, Inc. (CRCI) provides a complete range of clinical research consulting services to the clinical divisions of the pharmaceutical and biotechnology industry with specialization in: ...
3R's Management Consulting and Therapeutics, Inc.  Powerful dual track career in clinical aspects of pharmaceuticals, chemicals, medical devices and diagnostics. Ideal senior scientist, project manager or both. In-depth experience managing clinical research and...
Trio Clinical Research  Trio Clinical Research is a contract research organization that specializes in clinical trial managment, functional outsourcing and resourcing for pharmaceutical, clinical trials.
CLINICAL RESEARCH MONITORING SERVICES Trio provides Clinical Monitoring services in support of our clients' clinical trial needs. Through our flexible operational model, we can provide Clinical...
CLINICAL RESEARCH RESOURCING SERVICES Trio collaborates with our clients to offer customized solutions to meet a variety of outsourcing needs. While many of our clients need to engage an entire...
PRC Clinical  PRC Clinical offers a full suite of world-class CRO services for Phase I -IV clinical trials. We are headquartered in the San Francisco Biotech corridor and serve virtual, small and mid-size pharma/biotech and medical...
Clinical Monitoring and Auditing Experienced Clinical Research Associates and Clinical Auditors; available when and where you need them.
Clinical Project Management Experienced management of Global Clinical Trials as well as consulting and ongoing support are available for Development and Planning and throughout the...
Reliance Clinical Research Services  RCRS, a CRO offers Preclinical Development, Phase I-IV Clinical Trial Management, Bioequivalence, Pharmacokinetic & Pharmacodynamic studies and Cardiac Safety studies, Pharmacovigilance, Biometrics, Regulatory Affairs,...
Phase 1 Clinical Trials Clinical Trials
Phase II-IV Clinical Trial Management and Monitoring Clinical Trial Management and Monitoring
Fortitude Clinical  Fortitude Clinical. Clinical Research Organisation (CRO), Site Management Organisation (SMO), and Generic Product Services in Asia Pacific. Headquartered in Singapore.
Clinical Ink  Clinical Ink’s FDA compliant eSource technology replaces EDC and CRFs, eliminates SDV, and enables real-time data availability and remote monitoring of clinical trial data.
ChartRoom™ Access to source data is securely controlled via our ChartRoom™. Before a source document can be modified, it must be checked out and downloaded to a...
SureSource Clinical Ink offers an Electronic Source Record (ESR) for clinical trials that provides cleaner data more quickly — saving money by eliminating SDV,...
Onorach Clinical  Onorach Clinical manage Phase I to Phase IV clinical research studies for drug products, biologicals and medical devices. Onorach have a global reach and can work with clients of any size.
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Clinical Trial Monitoring - Product Reviews

Education in clinical trial monitoring is seen as the differentiator in staving off FDA from derailing trials.

“Better to get bad news from us than from the FDA,” says trial monitor Mary Maddock, during a MedCity News interview. Ultimately, every successful clinical trial must safely negotiate the rocky shoals of trial monitoring in order to win coveted FDA approval. A good trial monitor can speed trials and smooth the regulatory approval process.

“Education helps keep researchers from making mistakes,” adds Neal Fearnot, chairman of MED Institute Inc. in West Lafayette, IN. “Significant education for the staff, physicians, hospital administrators–anybody who’s on site and involved with running the clinical trial.” Education helps to avoid an FDA Form 483 warning, which is followed by significant added paperwork for the violation… and/or a complete halt to the clinical trial.

Best-in-Class Clinical Trial Monitoring Features:

  • Oversight, administrative due diligence, and ongoing education by monitors throughout the trial’s duration
  • Data collection and analysis throughout a project to ensure appropriateness of the research and project design.
  • Comply with informed consent and human subject protection requirements

Top Considerations before Engaging Clinical Trial Monitoring Providers:

From project management and clinical trial monitoring or simply to supplying a small team of monitors to work on a study, providers should be experienced in clinical site monitoring, experienced across all phases of development and major therapeutic areas, possess the ability to recruit, educate and train both test subjects and staff for either regional or in-house monitoring.
Key Products:

1. With a network of in-house and contract clinical research associates with expertise in a wide range of therapeutic areas, Statking Consulting provides laboratory pre-study qualification visits, clinical study monitoring, initiation plan monitoring, close-out monitoring visits, and clinical study monitoring report. With a network of in-house and contract clinical research associates with expertise in a wide range of therapeutic areas, Statking Consulting provides laboratory pre-study qualification visits, clinical study monitoring, initiation plan monitoring, close-out monitoring visits, and clinical study monitoring report. A data-related service Contract Research Organization (CRO), Statking Consulting, Inc. was founded in 1989 and has provided support on over 250 clinical trials. In addition to providing biostatisticians, data managers, clinical study monitors, project managers and medical writers for clinical research teams, Statking Consulting offers protocol development, IRB submissions, site and laboratory qualification, regulatory documentation, investigator meetings, drug/device accountability.

2. Stiris Research Inc. offers site identification and feasibility studies, site qualification visits, site activation, informed consent review,  review of policies, procedures and documentation, data collection (electronic or paper), query resolution, and ongoing monitoring of site/study recruitment. Founded in 2004 as an independently owned, clinical research consulting company, Stiris Research provides functional service or full service clinical trial support for pharmaceutical, biotech, and device companies. In 2009, in order to automate the clinical trial process, Stiris Research implemented clinical trial management software (CTMS) from Clinical Force.

3. Providing integrated solutions from preclinical activities to Phase I-IV trials, bioanalytical, trial monitoring, and QC testing, SGS's Life Science Services is a global contract service organization, with further capabilities for rapid access to special patient populations for time-critical trials.  SGS serves the pharmaceutical, biotechnology and medical device industries. An experienced global CRO for 30 years with over 2,000 clinical trials performed, SGS has two Phase I centers in Europe (Paris/Antwerp) with 184 total beds; Phase I-IV clinical trial coordination centers in ten offices covering Europe and the US; and  two bioanalytical laboratories in France and Belgium. Clinical trial management specialties in infectious diseases, CNS and cardiology; biometrics pioneer in use of EDC systems for Phase I to IV studies and monitoring.

4. Essential Group (now part of InVentivClinical) offers in-house and regional trial monitors with an average of more than 13 years of experience in clinical site monitoring. Essential Group offers protocol development and study design, feasibility study, project management, rapid study startup, clinical monitoring, medical monitoring, data management, patient recruitment and retention, statistical analysis, medical writing, PI training services as well as patient recruitment and retention services. Essential Group was founded in 1994 and formerly known as AmericasDoctor, Inc. (until name change in January of 2005). The company’s client base consists of pharmaceutical, biotech, nutritional and medical device companies. As of February 20, 2010, Essential Group was acquired by inVentiv Clinical Solutions, LLC.

5. ClinAudits specializes in conducting GCP audits, GLP audits, GMP audits, and GTP audits, but does not conduct or manage clinical trials. The company performs multiple types of audits in GCP, both domestically and internationally including, but not limited to, investigator sites, CRO (pre-qualification or post capability), IRB, final study reports, central labs, phase 1 units, computer validation, and mock FDA/EMEA pharma-covigilance and database audits. ClinAudits provides Good Clinical Practice (GCP) regulatory compliance and auditing services to the pharmaceutical, medical device, biotechnology, biologics industries, and to major academic institutions.

Clinical Trial Monitoring
Definition: Clinical Trial Monitoring of a clinical trial requires oversight and administrative efforts that monitor the trial throughout its duration, including data collection and analysis throughout a project to ensure appropriateness of the research and project design, validity and integrity of the data, and protection of human any subjects.


Clinical Trial Monitoring Research Library

Rat KidneyMAP
Myriad RBM, Inc.
A 12-Biomarker Multi-Analyte Profile (MAP) for Detecting Kidney Toxicity in Rat Preclinical Drug Studies. Sherry Sours-Brothers, Ph.D. and Dominic Eisinger, Ph.D. Introduction Rat KidneyMAP® and Biomarker Qualification by the Predictive Safety Testing Consortium Drug induced toxicity is responsible for killing 30% of promising compounds from early preclinical studies and can negatively impact ...
Case Study – Sterling Research
Bio-Optronics Inc.
Sterling Research Group began using Clinical Conductor Site CTMS in 2008. Prior to using the Clinical Conductor CTMS system, Sterling Research Group used a combination of manual methods combined with an underperforming CTMS system that did not meet the needs of their growing organization. This case study will analyze the problems faced by Sterling Research Group, the Clinical Conductor Site CTMS ...
Just in Time: Monitoring
Just­in­Time: Taking a New Approach to Monitoring Careful monitoring is a necessary and important part of any clinical trial – so necessary and important, in fact, that it has changed very little over the history of conducting clinical trials. Required by both US and international agencies, clinical trial monitoring helps ensure the integrity of the data, the consistency of the science, and the ...
The True Cost of a Clinical Trial Management System (CTMS)
Trial By Fire Solutions, LLC
Read key issues to consider when evaluating a Clinical Trial Management System (CTMS). Top of mind should be the fiscal and resource commitment; flexibility requirements; and system accessibility: locally and globally.
HIV Clinical Trials- Recent Changes in the Environment
SGS Life Science Services - Clinical Research
Over the past number of years HIV medication development mainly focused on treatment simplification with the development of fixed dose combination tablets. However, during the last two years, significant progress was made to increase the number of new compounds available to patients; not only did the FDA approve a new protease inhibitor (duranavir, 2006) and a NNRTI (Etravirine, 2008), there was ...

Clinical Trial Monitoring Video

What Makes a Great CTMS Development Team? Bio-Optronics Inc. Mike Kamish, Founder and Chief Technology Officer of Bio-Optronics, discusses the state of clinical research, the factors impacting an organizations ...
iMedNet EDC - an eClinical Solution MedNet Solutions iMedNet EDC is an innovative, SaaS-based eClinical technology platform that allows non-technical sponsor and CRO personnel to quickly, easily and ...
Clinical Trial Monitoring Myriad RBM, Inc. Company

Clinical Trial Monitoring News

Clinical Trial Monitoring MedNet Solutions Products
Clinical Trial Monitoring The Jackson Laboratory Products
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