Newsletter: 2017 Oct

Oct 3, 2017 – CliniOps turns 4!!

It has been an interesting journey over the past 4 years, staying at the cutting edge of innovation and technology in the Life Science industry. What started off with two founders working out of a garage, CliniOps now has offices in US and India and a bigger team, to support the growing needs of our customers. In the first phase of this journey, we worked very closely with our early adopters, and thought leaders in the space with a lazer focused effort on developing a product that brings a transformational change in solving the clinical data management problems. The next phase of our journey was to ensure that a robust quality management and security management processes were in place to ensure data compliance, data security and other regulatory requirements. During this phase, we worked closely with KPMG as part of our validation exercise. With that behind, we are now focused on building a world-class customer support and global delivery team. The goal is to ensure that our customers receive their best experience working with us, and can trust and count on us whenever needed. We are currently working with several Pharma, BioTech, CRO, Academic Institutions and Global Health Foundations, supporting studies across North America, South America, Asia and Africa. And we feel happy to say that ‘We are fueled by the energy of our team and the satisfaction of our customers’.

Quarterly Updates Jul – Sep 2017

Global efficacy study

CliniOps started a new 2,800 patient study, across 4 countries – Papua New Guinea, Haiti, India & Indonesia. Each location had its own set of challenges and requirements both from a regulatory perspective and local/social practices. CliniOps team worked closely to understand these requirements and configured the solution for a near seamless go-live.

Clinical Data Management

CliniOps provided its data management and statistical analysis services to a Pharmaceutical company working on Catheter Lock Solution in Hemodialysis, to streamline its Phase 3 clinical study. The data was published to FDA and the analysis was part of an article published in the Clinical Infectious Diseases Journal.

Supporting a new study in South America

CliniOps started two new medical device studies on Coronary & Peripheral CTO Crossing System, with sites in South America. We are working closely with the sponsor team and the site team on the ground to ensure that the CliniOps product is configured right to best suit the site workflow.

Innovation That Matters

Subject Visit in CliniTrial eSource solution, now integrated with Outlook

Managing patient visit schedules during clinical trials can be a daunting task. However, with the right tools in place, organizations can significantly streamline this process and increase compliance and protocol adherance. That’s where CliniTrial eSource solution can help with its built-in visit calendar directly integrated to your Outlook or calendars of your choice.

A protocol deviation is generally considered to be a departure from the study protocol, or other study-related documents, that has not been approved by an institutional review board (IRB). One frequently observed deviation in clinical trials is an “out-of-window” visit. When writing the protocol, the investigator and sponsor should carefully consider setting window visits. Also, need to be aware of the time of year and the anticipated start and length of the study, because planned vacations or national holidays can throw a wrench in the study timelines. If study subjects miss their visit window by several days (for reasons of illness, forgotten schedules, lack of transportation, etc.), it is considered a deviation. All these protocol requirements are incorporated as part of the subject calendar and its integration with outlook helps better manage the same.

Going beyond CRFs with enhanced Source data capture

CliniOps has implemented several features and capabilities to streamline the process of data collection via the tablets. Cutting edge technology on mobile platforms can not only increase the data quality at point-of-care significantly, but also makes the process very seamless. Device data can now be collected over bluetooth directly from our CliniTrial application. We have also developed built-in capabilities to capture Bar Codes, digital signatures, electronic approvals, Speech 2 Text. In addition, Image field helps collect pictures (of patient skin rashes etc). Scale field helps collect pain levels. Apart from these, intelligent use of Radio buttons, Numeric Fields, Date Field, Time field, and Pre-built drop-down menus helps with structured data collection, minimizing free text and reducing data entry errors. There is also the option to collect free-text data as needed.