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Related Concept Videos

Clinical Trials01:16

Clinical Trials

8.5K
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
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Clinical Trials: Overview01:11

Clinical Trials: Overview

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Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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Preclinical Development: Overview01:28

Preclinical Development: Overview

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Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
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Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

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Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...
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Nursing Clinical Information System01:27

Nursing Clinical Information System

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Nursing Clinical Information System (NCIS)
A Nursing Clinical Information System (NCIS) is a specialized type of healthcare information system tailored to meet the unique needs of nursing practice. It incorporates the principles of nursing informatics to streamline information management and improve the quality of care delivery.
Critical attributes of NCIS include:
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Drug Administration and Therapy Phases: Overview01:26

Drug Administration and Therapy Phases: Overview

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Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
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E-Patient Counseling Trial E-PACO: Computer Based Education versus Nurse Counseling for Patients to Prepare for Colonoscopy
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An overview of e-Clinical trials.

Graham Bunn1

  • 1EMEA Medidata Solutions Worldwide, 120 Bridge Road, Chertsey, UK KT16 8LA.

Drug Discovery Today. Technologies
|July 2, 2014
PubMed
Summary

e-Clinical systems in clinical trials are evolving from replacing paper records to fully integrated platforms. This progression enhances pharmaceutical research and development through advanced e-Clinical trial solutions.

Area of Science:

  • Clinical Research Informatics
  • Pharmaceutical Science
  • Health Informatics

Background:

  • The clinical trials industry is transitioning from paper-based processes to digital solutions.
  • e-Clinical systems represent a significant advancement in managing clinical trial data and operations.
  • The evolution of e-Clinical systems is driven by the need for efficiency and integration in pharmaceutical R&D.

Purpose of the Study:

  • To define the stages of e-Clinical systems adoption in clinical trials.
  • To analyze the business drivers and advantages associated with e-Clinical systems.
  • To examine current trends supporting a fully integrated, paperless e-Clinical environment.

Main Methods:

  • Review and categorization of industry progress in e-Clinical systems.

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  • Discussion of business drivers and examples at each stage of adoption.
  • Analysis of current industry trends and future vision for e-Clinical integration.

    • Main Results:

    • Three distinct stages of e-Clinical systems development identified: standalone replacement, system integration, and a fully integrated 'SAP for Clinical Trials' vision.
    • Key business drivers and advantages are associated with each stage of e-Clinical adoption.
    • Current trends indicate a strong movement towards paperless, integrated e-Clinical environments.

    Conclusions:

    • The adoption of e-Clinical systems is progressing through defined stages, enhancing clinical trial efficiency.
    • A fully integrated, paperless e-Clinical environment, akin to an 'SAP for Clinical Trials', represents the future of pharmaceutical R&D.
    • Continued industry trends support the realization of this integrated future, optimizing research and development processes.