• About
  • Privacy & Policy
  • Contact
Saturday, May 28, 2022
  • Login
MYTECHMAG-A Leading Technology Magazine
CCUS Top Banner
Exhivits The Virtual Exhibition Top Banner
LNG Top Banner
Digital Transformation Conference Top Banner
Energy Storage Top Banner
Data Driven Oil & Gas 2022 Top Banner
Labware Top Banner
Renewable Energy Power Purchase Agreements Top Banner
Cyber Defense Top Banner
Qube Events NPF Top Banner
Payments Summit Europe Top Banner
OGAD Top Banner
Project Finance & Project Financial Modelling Top Banner
  • Home
  • Technology
    • Supply Chain
    • Enterprise Security
    • Cloud Technology
    • RegTech
    • HPC
    • Collaboration
    • IOT
    • Compliance
    • Artificial Intelligence
    • Field Service
    • CRM
    • Project Management
    • Fintech
    • Risk Management
    • Cyber Security
    • Enterprise Architecture
    • EAM
    • ECM
    • Block Chain
    • Data Analytics
    • Robotics
    • Disaster Recovery
    • Marketing
  • Industry
    • Retail
    • Healthcare
    • Construction
    • Pharma
    • Education
    • Textile
    • Aerospace and Defense
    • Banking
    • Smart City
    • Oil and Gas
    • Telecom
    • Travel & Hospitality
    • Agri Tech
    • Media & Entertainment
    • Logistics
    • Manufacturing
    • Legal
    • Government
    • Real Estate
    • Automotive
    • Food and Beverage
    • Biotech
    • HR
    • Insurance
    • Energy and Utilities
    • Contact Center
    • Capital Market
    • Chemical
    • Sports
  • Solution Providers
    • Aerospace and Defense
    • Agri Tech
    • Artificial Intelligence
    • Automotive
    • Banking
    • Capital Market
    • Cloud Technology
    • Collaboration
    • Construction
    • Contact Center
    • CRM
    • Cyber Security
    • Data Analytics
    • Disaster Recovery
    • EAM
    • ECM
    • Energy and Utilities
    • Enterprise Architecture
    • Enterprise Security
    • Fintech
    • Government
    • Healthcare
    • Insurance
    • IOT
    • Legal
    • Logistics
    • Manufacturing
    • Marketing
    • Oil and Gas
    • Pharma
    • Retail
    • Risk Management
    • Smart City
    • Supply Chain
    • Top CEOs
  • Magazines EditionsMost Clicked
  • News
  • Featured Articles
  • Top CEOs
  • Events
No Result
View All Result
  • Home
  • Technology
    • Supply Chain
    • Enterprise Security
    • Cloud Technology
    • RegTech
    • HPC
    • Collaboration
    • IOT
    • Compliance
    • Artificial Intelligence
    • Field Service
    • CRM
    • Project Management
    • Fintech
    • Risk Management
    • Cyber Security
    • Enterprise Architecture
    • EAM
    • ECM
    • Block Chain
    • Data Analytics
    • Robotics
    • Disaster Recovery
    • Marketing
  • Industry
    • Retail
    • Healthcare
    • Construction
    • Pharma
    • Education
    • Textile
    • Aerospace and Defense
    • Banking
    • Smart City
    • Oil and Gas
    • Telecom
    • Travel & Hospitality
    • Agri Tech
    • Media & Entertainment
    • Logistics
    • Manufacturing
    • Legal
    • Government
    • Real Estate
    • Automotive
    • Food and Beverage
    • Biotech
    • HR
    • Insurance
    • Energy and Utilities
    • Contact Center
    • Capital Market
    • Chemical
    • Sports
  • Solution Providers
    • Aerospace and Defense
    • Agri Tech
    • Artificial Intelligence
    • Automotive
    • Banking
    • Capital Market
    • Cloud Technology
    • Collaboration
    • Construction
    • Contact Center
    • CRM
    • Cyber Security
    • Data Analytics
    • Disaster Recovery
    • EAM
    • ECM
    • Energy and Utilities
    • Enterprise Architecture
    • Enterprise Security
    • Fintech
    • Government
    • Healthcare
    • Insurance
    • IOT
    • Legal
    • Logistics
    • Manufacturing
    • Marketing
    • Oil and Gas
    • Pharma
    • Retail
    • Risk Management
    • Smart City
    • Supply Chain
    • Top CEOs
  • Magazines EditionsMost Clicked
  • News
  • Featured Articles
  • Top CEOs
  • Events
MYTECHMAG-A Leading Technology Magazine
No Result
View All Result
MYTECHMAG-A Leading Technology Magazine
No Result
View All Result
Home Healthcare

Clinical Trials: Discovering Drugs

Elizabeth Cole by Elizabeth Cole
July 10, 2018
in Healthcare
Clinical Trials Discovering Drugs
19
SHARES
74
VIEWS

Today one can say that clinical trials have become increasingly costly initiatives, adding to largely the cost of developing a drug and, eventually, the price that patients pay for those drugs. Today bigger pharma companies and small biotech firms are looking for pioneering ways to develop trial outcomes and, also at the same time lower trial costs — this means increasing the effectiveness in which they recruit patients, monitoring more closely how drugs are supplied and being lither about trial design. Through technology, a lot of tools are assisting these organizations to optimize clinical trials today.

Technology involvement:

It is not new that technology has been very much present in the clinical trials sector for years. Technologies like Clinical Trial Management Systems (CTMS), Electronic Data Capture (EDC) and Patient Recorded Outcomes (PRO) have transformed into a rule; however, technology is now playing an essential role in the overall clinical study strategy. IT giants who are Google, Apple and Amazon, are also looking for a large piece of the clinical trial sector by increasing technologies that center on patient centricity. Market leaders such as Oracle, Medidata and Veeva are enduring to increase extensive technology platforms for clinical trials.

Higher quality standards:

Regulations are focusing on enhancing patient safety and raising the bar when it comes to Quality Management Systems and on the whole quality assurance practices. The ICH GCP E6 (R2) regulations intimate taking a risk-based approach to quality assurance by following ISO norms and execute best practices. Organizations will be looking for specialist and niche providers in this sector.

Data privacy and transparency alongside anonymization:

This year has been all about safeguarding citizen privacy. The European Union has adopted significant measures to guarantee data privacy via the General Data Protection Regulation (GDPR) which is applicable to all companies managing data in the EU. The European Union is also set to execute Clinical Trial Regulation 536/2014 which calls for an EU portal printing clinical study results once a Marketing Authorization Application (MAA) has been submitted. This calls for the elimination of patient identifiers and the de-identification of data.

Understanding regulatory requirements:

There are numerous other significant regulations, apart from GDPR and Clinical Trial Regulation 536/2014 that sets to give results especially in the areas of clinical data management, regulatory submissions, pharmacovigilance reporting, and medical device trials. Fines are said to be made severe for non-compliance, and therefore budget for the extra regulatory support should be in mind.

Data Analytics is Necessary:

Centralized analytical monitoring is being discussed more often as Sponsors look to assist risk-based monitoring with real-time, accurate metrics. Data analytics has started playing an even greater role in these critical strategic decisions for Sponsors. The ICH GCP E6 (R2) regulations place a massive emphasis on oversight and lay the accountability of clinical trial conduct on the Sponsor.

Pharmacovigilance outsourcing (PVO):

Pharmacovigilance Outsourcing has started getting its own acronym and attention of late. The management and reporting of unfavorable events are becoming a complex business, and new regulations are making it trickier for Sponsors to work without support from specific experts. In Europe, for example, there are new developments to the Eudravigilance system for the reporting of complex events.

Medical Device regulations:

EMA and FDA have examined the medical equipment trials in the past year, and the FDA is looking at the conduit for medical device approvals. The EU has set forth a new framework for medical device trials together with an EU-wide coordinated procedure for multi-center investigations and superior transparency. Medical device firms need to appear at how they are managing data. Alongside Biotechs which now have multiple outsourcing models available including Functional Service Provision to allow them to continue developing their product and this may lead to an enhanced clinical trial procedure.

Tags: clinical trialsdrugs trials
Share1Tweet5Share8
Previous Post

Top Pioneering CEOs in 2022

Next Post

Apps in Healthcare: Connecting Patients with Care Providers

Elizabeth Cole

Elizabeth Cole

Related Posts

Concordance Healthcare Solutions
Healthcare

Concordance Healthcare Solutions – Overview & Reviews

May 2, 2022
Sunset Healthcare Solutions
Healthcare

Sunset Healthcare Solutions – Overview & Services

April 29, 2022
Avalon Healthcare Solutions
Healthcare

Avalon Healthcare Solutions – All You Need to Know

April 28, 2022
Next Post
Apps in Healthcare - Connecting Patients with Care Providers

Apps in Healthcare: Connecting Patients with Care Providers

OGAD Side Banner
CCUS Side Banner
Renewable Energy Power Purchase Agreements Side Banner
Data Driven Oil & Gas 2022 Side Banner
Cyber Defense Side Banner
Qube Events NPF Side Banner
Energy Storage Side Banner
Digital Transformation Conference Side Banner
Exhivits The Virtual Exhibition Side Banner
LNG Side Banner
Payments Summit Europe Side Banner
Project Finance & Project Financial Modelling Side Banner
Tweets by MyTechMag
LNG Side Banner
MYTECHMAG

Transforming news into insights, not only do we serve as a source of information but as the breeding ground for innovative ideas and exchange of breathtaking strategizes that can make a difference in your technological understanding.

Follow Us

  • Home
  • About Us
  • Disclaimer
  • Privacy Policy
  • Terms of Use
  • Sitemap
  • News
  • Subscribe
  • Contact Us
  • RSS
  • Write For Us

Recent Posts

What is the Impact of Aerospace and Defense on the US Economy?

What is the Impact of Aerospace and Defense on the US Economy?

May 25, 2022
Stephen Kosslyn

Stephen Kosslyn Net Worth, Biography, Age, Career, Salary & More 

May 24, 2022
  • About
  • Privacy & Policy
  • Contact

© Copyright © 2022 MYTECHMAG. All Right Reserved.

No Result
View All Result
  • Home
  • Technology
  • Industry
  • Solution Providers
  • Magazines Editions
  • News
  • Featured Articles
  • Top CEOs
  • Events

© Copyright © 2022 MYTECHMAG. All Right Reserved.

Welcome Back!

Login to your account below

Forgotten Password?

Retrieve your password

Please enter your username or email address to reset your password.

Log In