Demand-led Supply: Increasing Efficiency in Clinical Studies Logistics
Cost pressures associated with the development of new medications are at an all-time high for the pharmaceutical industry. Drug development…
Read more
How Integration of Consumer and Medical Devices is Reshaping Clinical Trials
The advent of continuous data monitoring using wearable technology and other connectable medical devices has opened the door to new…
Why would Cardiovascular Outcomes Trials and Rare Disease Studies have Anything in Common?
Cardiovascular outcomes trials (CVOTs) are some of the largest interventional trials being conducted, enrolling several thousand subjects, sometimes with follow-up…
Bridging the Clinical Data Structure Gap to Empower Holistic Risk Management
Per the suggestion of regulatory agencies, there is an increased focus on the merits of adapting a risk-based monitoring (RBM)…
Why and How a Research Lab Should Embrace Research Quality
The development of therapeutic products balances benefits and adverse consequences, so research quality is required for the development of the…
Latest FDA Guidance on Non-Inferiority Designs
To obtain drug approval from the US Food and Drug Administration (FDA), manufacturers must establish efficacy by providing “substantial evidence”…
Integrative Approach to the Conduct of Rare Disease Clinical Trials
The planning and execution of rare disease clinical trials involves unique considerations. Examples include the role of patient advocacy groups,…
Human Challenge Studies: An Effective Tool for Drug Development
Human challenge studies (HCS) were introduced as an alternative to community clinical trials for anti-infective agents and vaccines, previously performed…
Policy 0070 Under the Microscope: The Trade-off Between Clinical Trial Transparency and the Risk of Revealing Patient Identities
The last few months have seen a battle build between the pharma industry and the EMA, following the issue of…
Five Reasons to Embrace the ICH E6 (R2) Addendum Now: Improve Study Efficiencies by Centralising Risk-based Quality Oversight and Trial Management
In November 2016, the ICH E6 (R2) Addendum to Good Clinical Practice was implemented, delivering a breath of fresh air…