The Covid-19 pandemic has pushed the global clinical trial industry and regulators to rapidly adopt technology and accelerate clinical development. Along with other technologies, adoption of AI & ML has moved forward at a much more rapid pace than initially envisioned. Similar to remote technologies, AIML technologies have gone beyond user’s expectations and have quickly occupied a central position in an organisation’s plans for the future. Pfizer’s 45,000 subject Covid-19 vaccine study which was completed in record time with the help of AIML is a case in point. Looking at the big jump in ..read more

Anchoring the advancements in the field of drug development, the pharmaceutical industry has been progressing at a rapid pace. But despite significant investments in the development of modern therapies and treatments, the overall efficiency of pharmaceutical R&D efforts have been declining steadily. The increasing timelines and cost associated with clinical trials has been widely recognized as a key contributor to the trend. The pressure of the current epidemic has brought into greater focus the need for revolutionizing the functioning of the pharmaceutical sector. Vaccine development has ..read more

There are many benefits by using Clinion ePRO During the COVID-19 Pandemic During the ongoing COVID-19 crisis, CROs and Pharmaceutical companies are facing myriad of challenges. Many clinical trial studies have either slowed down or completely stopped due to the ongoing crisis. With medical staff directed to support the growing need for health workers, hospitals have little to no resources to spare for any other activities. COVID-19 Vaccine / Medicine Studies and Our Learnings from it Clinion has supported many companies to run their clinical trials operations during the pandemic. This include ..read more

With COVID-19 unleashing catastrophe across the world, everyone is looking up to pharmaceutical companies to come up with a solution. Pharmaceutical companies are currently racing to create vaccines to slow down and potentially eradicate the ongoing pandemic. It is hard to remember when a progress of vaccine development made it to the news and to the speeches of political leaders. With so much pressure on them, pharma companies need the best of the solutions to achieve this. There are many EDC platforms in the world today. However, when it comes to quick scale in clinical trials, many factors ..read more

The Clinion EDC platform is being offered to researchers at a discounted price in their fight against the Covid-19 virus. As of May 15, Clinion is already supporting multiple Covid-19 studies. We have developed a mobile Patient Reported Outcomes (ePRO) application within a span of 2 weeks to manage decentralized patient participation and remote monitoring of subjects. The mobile platform takes care patient enrolment, eConsent and Symptom tracking. The mobile application is integrated with Clinion’s Electronic Data Capture (EDC) system. Investigators and study personnel can monitor patients in ..read more

To be compliant with US FDA 21 CFR Part 11 regulations, CFR Part 11 validation of electronic data management systems is mandatory. In simple terms, any computerized system involved in the clinical research process must comply with FDA 21 CFR Part 11. What is US FDA 21 CFR Part 11? It is basically part 11 of Title 21 of the Code of Federal Regulations. This sets rules as to how any company implementing digital signatures and electronic records capturing or dealing with clinical data must comply with FDA regulations. Established in 1996, Part 11 has had several versions released to keep abreast ..read more

Clinion CTMS – Discover, Transform and Enhance your Clinical Trials Clinical Trials are a humongous undertaking. They involve massive amounts of data, hundreds of people and many sites for investigation. Managing these trials in the highly regulated clinical research field is challenging. It involves the integration of various processes, risk management and adherence to stringent schedules. Clinion CTMS (Clinical Trial Management System) has been designed to simplify this complex operation and bring all the various elements of a study working together harmoniously under one system.  Clini ..read more

Clinion CDMS – Solutions to deliver high quality, quick and productive clinical studies We at Clinion understand how clinical data can completely impact the cost, effectiveness and turnaround time of any clinical study. Clinion’s Clinical Data Management System (CDMS) works towards storing and managing EDC and Paper-based data of clinical studies. The clinical data gathered as a result of the investigative process is stored in CDMS. Clinion’s CDMS is responsible for collecting, cleansing and maintaining accurate, high-quality data compliant with all regulations. The key function of our CDMS i ..read more

Electronic Data Capture(EDC) is used to help medical device and pharmaceutical organizations accomplish the greatest effectiveness with regards to entering data, structuring a database and conducting analysis for clinical trials. EDC technology has developed as past worries about data integrity through human error and connectivity issues caused by less reliable IT systems have become a thing of the past. In the course of the most recent decade, the utilization of EDC in clinical trials has become more prominent. As the medical industry embraces new technologies and innovations, including elect ..read more