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Location Settings

Asia-Pacific

AU -  Sydney
AU -  Melbourne
AU -  Brisbane
CN -  Hong Kong
CN -  Shanghai
IN -  Bangalore
MY -  Kuala Lumpur
PH -  Metro Manila
CT -  Taipei City
CT -  Taipei City
TH -  Bangkok
NZ -  New Zealand
KR -  Seoul (Gangnam)
KR -  Gyeonggi-do
KR -  Seoul City Airport

North America

US -  Boston
US -  South Carolina

GLOBAL

English

The Challenges and Opportunities of Virtual Clinical Trials

Virtual Clinical Trials (also known as Decentralised Trials and Siteless Trials) bring clinical trials directly into the participant’s home via a central and virtual coordinating site. Vital equipment like the Investigational Product, and wearables are delivered to the participant while support by study physicians and pharmacists is offered via video conferencing. Mobile health applications and telehealth technologies are used to collect medical data from participants and transmit it to the central study centre.  

What is an Investigator Site File (ISF)?

An Investigator Site File (ISF) contains essential documents which shows that the clinical trial site and Investigator are following the regulatory requirements set out by the ICH GCP guidelines. According to the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines, essential documents are defined as “documents which individually and collectively permit evaluation of the conduct of the trial and the quality of the data produced.” The ICH GCP 4.9.4 guideline states that

Corrective and Preventive Action

CAPA (Corrective and Preventive Action) is a quality system plan which aims to resolve compliance issues and to prevent any further recurrences. A CAPA plan is crucial to a clinical trial as it helps keep trial participants safe and protects their rights. It also prevents the study data from being compromised. 

CAPA processes include:  

Accelerating Clinical Trials in Rare Disease - Understanding Asia’s success as a rare disease clinical trial location

Josh Knowles: Good morning, good afternoon, everyone, depending on where you're joining us from, and welcome to today's webinar. My name is Josh from Business Review Webinars, and I will be your host. It is our pleasure to have Novotech with us today who will be presenting the webinar entitled Accelerating Clinical Trials in Rare Disease.

Data Monitoring Committee

Data Monitoring Committees (DMCs) also known as Data Safety Monitoring Boards (DSMBs) and Data Monitoring and Ethics Committee (DMEC) play a vital role in the safety of clinical trials and also enhance the validity and integrity of the results collected from trials.

Randomisation in Clinical Trials

The Use of Randomisation in Clinical Trials 

Randomisation Controlled Trials (RCT) is the process of randomly assigning participants to groups that receive different treatments, which ensures that each individual has an equal chance of receiving any of the treatments used in the clinical trial. It allows the trial staff to make unbiased and informed decisions about new treatments, and is usually considered the best way to evaluate the efficacy of a new treatment and the effectiveness of interventions. 

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