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March 14, 2023 FAQ

What are the benefits of a well-designed, robust preclinical development plan?

Felicity Grzemski PhD DABT

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December 14, 2022 FAQ

The FDA and Clinical Trials

In America, the FDA (Food and Drug Administration) was established as a federal agency in 1906 with the Pure Food and Drug Act.

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November 16, 2022 FAQ

Clinical Data Management: Past, Present and Future

Clinical Data Management (CDM) is an integral part of clinical trials and enables clinical trial staff to extract valuable, accurate, high-quality data during the clinical trial process.

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November 11, 2022 FAQ

Types of Clinical Data Management

Clinical Data Management (CDM) deals specifically with the information that is collected during the clinical trial.

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October 31, 2022 FAQ

Contract Research Organisations and the Different Roles They Play

A Contract Research Organisation (CRO) provides research services to the biotechnology, pharmaceutical and medical device industries through a contract agreement.

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October 27, 2022 FAQ

Contract Research Organisations: Market and Trends

The Contract Research Organisation (CRO) industry is constantly changing and growing due to various key factors like a growing healthcare sector, research funds, a growing patient population worldw

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October 20, 2022 FAQ

The Future of Contract Research Organisations

Contact Research Organisations (CROs) have undergone many changes over the past few years, thanks to the COVID-19 pandemic and technological advances.

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September 30, 2022 FAQ

Bioinformatics

Bioinformatics is the scientific discipline that includes the use of computers to collect, store and analyse information relating to biological data.

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September 21, 2022 FAQ

DNA and RNA

DNA (Deoxyribonucleic Acid) is the genetic material found inside cells responsible for a living organism's development and function.

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September 12, 2022 FAQ

Pharmacogenomics

Pharmacogenomics is the study of how a person’s DNA responds to drugs.

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August 26, 2022 FAQ

Biosafety

According to the World Health Organisation (WHO): “Biosafety is a strategic and integrated approach to analysing and managing rel

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August 22, 2022 FAQ

Bioprospecting and Biopiracy

Bioprospecting is the search for and the commercialisation of new products that have been sourced from nature.

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July 29, 2022 FAQ

Biobanks and Biotechnology

Biobanks are storage facilities that house blood samples, DNA, tissue samples and tumour cells that are used for research purposes.

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April 1, 2022 FAQ

Clinical Trends of 2022

2022 marks the third year of the worldwide COVID-19 pandemic, which continues to fuel the transformation of the clinical trial and the research industry.

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March 2, 2022 FAQ

What is the Driving Force Behind China’s Biotech Revolution?

In 2011, China stated that its biomedicine industry was one of seven strategic priorities, and in its Five-Year Plan (2015-2020), the Chinese government mandated that the biotechnology sector should exceed 4% of GDP (Gross Domestic Product) by 2020 in market size.

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February 7, 2022 FAQ

Clinical Development Strategies for Western Biotech Companies in China

Since 2015, the medical and research industries in China have seen a huge shift with their regulatory processes and framework, which is helping to pave the way for Western biotechnology companies t

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October 29, 2021 FAQ

Virtual Clinical Trials in Asia and Australia

The COVID-19 pandemic has had an impact on clinical trials around the world with the research and medical industry having to adapt to the ongoing challenges.

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October 18, 2021 FAQ

Monitoring Participants in a Virtual Clinical Trial

Monitoring is a crucial element of any clinical trial, with The National

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October 18, 2021 FAQ

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.

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October 8, 2021 FAQ

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.

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October 8, 2021 FAQ

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.

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August 13, 2021 FAQ

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.

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August 13, 2021 FAQ

Reporting Serious Breaches in Clinical Trials

A ‘Serious Breach’ is defined as being a breach of Good Clinical Practice or clinical trial protocol which has an impact on the safety or rights of a clinical trial participant, and the reliability

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July 28, 2021 FAQ

What is an Investigator’s Brochure?

An Investigator’s Brochure is a collection of clinical and non-clinical data about the investigational products that are the focus of the study.

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July 28, 2021 FAQ

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 ens

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June 10, 2021 FAQ

What is a Trial Master File? (TMF)

A Trial Master File (TMF) is a compilation of documents that prove that the clinical trial has been conducted following regulatory requirements (including Good Clinical Practice).

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June 3, 2021 FAQ

What is a Case Report Form?

A Case Report Form (CRF) is an electronic or paper document which is used in a clinical trial to record the protocol and required information about each particip

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April 30, 2021 FAQ

Data Management in Clinical Trials

Clinical Data Management (CDM) is the process of putting together, handling, collecting and analysis of clinical data, which is done in accordance with regulatory requirements.

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March 29, 2021 FAQ

The importance of control groups in clinical trials

A control group refers to a group of clinical trial participants who do not receive the drug or treatment being studied in the trial but instead receive standard of care or a placebo.

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March 24, 2021 FAQ

What makes a Good Clinical Trial Site

The site selection is crucial to the outcome of a clinical trial; it has the power to either make or break it.

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March 17, 2021 FAQ

Good Clinical Practices

Good Clinical Practice (GCP) is defined as being an “internationally accepted standard for the designing, conducting, recording and reporting of clinical trials.”

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February 25, 2021 FAQ

How to Recruit Participants and How Participants can Take Part

One of the most important and challenging parts of a clinical trial is finding participants who are willing to volunteer to test out a new treatment.

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February 18, 2021 FAQ

Placebos: Why They Play an Important Role in Clinical Trials

Placebos are used to form a comparison point for new treatments, so the medication being tested can be deemed safe and effective.

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January 15, 2021 FAQ

Benefits of running clinical trials in Australia

Australia has the reputation of being home to a world-class research infrastructure with renowned health professionals and researchers overseeing clinical trials.

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December 14, 2020 FAQ

Glossary of Important Terms Related to Clinical Trials

The following list are common terms that are often associated with clinical research and trials.

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September 10, 2020 FAQ

Ensuring clinical trial participant safety

The safety of clinical trial participants is of paramount importance to CRO companies.

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September 9, 2020 FAQ

How to Understand the Structure of CRO Companies

CRO (Contract Research Organization) companies can vary in size from global companies to small specialized groups.

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July 29, 2020 FAQ

How CRO Companies Work? - A Basic Overview

It’s quite common for pharmaceutical and biotechnology companies introducing new drugs and treatment to outsource trials of new medication or procedures to CRO Companies.

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July 29, 2020 FAQ

How Long It Take a CRO Company to Complete a Clinical Trial?

Before any new medication or treatment can be administered to patients, it needs to undergo several clinical trial Phases which test the treatment for effectiveness and safety. Clinical trials conducted by clinical research organization companies can take on an average six..

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July 29, 2020 FAQ

How to choose a CRO Company for Clinical Research?

Selecting a reliable CRO clinical Research Company is crucial to the success of a clinical trial and pharma companies need to ensure they choose the right CRO Company to monitor and manage a project so it leads to a successful outcome.

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