Off the Record: The Truth about Data Integrity in Pharma

Apr 11, 2017

The Food and Drug Administration (FDA) has long emphasised the importance of reliable data in pharmaceutical manufacturing. Despite this clear recommendation, recent FDA reports have highlighted an increase in data integrity violations during several recent cGMP inspections. Lee Sullivan, Regional Manager at HMI/SCADA and software expert COPA-DATA UK, explores three data integrity pitfalls to which pharmaceutical manufacturers are most vulnerable. ...

Read More

Innovation to Resolve Challenging Microsphere Drug Delivery Systems Formulation Process

Apr 10, 2017

Due to their ground-breaking benefits and market share opportunity, the production of polymeric microsphere drug delivery systems is experiencing a fast-growing demand worldwide but remains a very challenging formulation process. New drug delivery devices such as PLA, PLGA, PLG or PEG polymeric microspheres have revolutionary applications. Camille Flores-Kilfoyle, Business Development Manager at Powder Systems Limited, submits a white paper on the drug delivery systems formulation process. ...

Read More

MALDI Mass Spectrometry in Drug Discovery

Apr 10, 2017

New MALDI technology looks set to boost discovery and early development of drug candidates, delivering new information and improved performance to scientists in both target selection and drug tissue distribution imaging. In this article, Dr Rohan Thakur, Dr Meike Hamester, Dr Dale Shannon Cornett and Dr Jens Fuchser at Bruker Daltonics guide us through the mentioned topic. ...

Read More

Leveraging Cloud-based EDC for Data Acquisition and Sharing

Jan 8, 2016

A primary challenge faced by clinical trial professionals around the world is the means by which data is collected and logged for their studies. There are three principle ways of recording this data: pen and paper, traditional computerised data capturing applications, and more recently, cloud-based electronic data capture (EDC). Glenn Keet, CEO of Clinovo, submits a technical article on cloud- based EDC. ...

Read More

Healthware – Beyond Bracelets and Watches

Jan 8, 2016

Norman J. Holter, regarded as the “Father of mobile ECG monitoring”, developed the world’s first ambulatory cardiology monitor, and arguably, the world’s first wearable device, in 1954. The device weighed 85 pounds and had to be strapped to the patient like a bulky backpack. For the very first time, the patient’s cardiac wellbeing could be tested in his natural state, at any point during the day. No longer did the physician wait by the patient’s bedside to detect an arrhythmia, nor did the testing have to happen in a controlled clinical environment. Bhargav Rajan, senior research analyst at TechVision, concentrates ...

Read More