CliniOps Celebrates 6th Anniversary!!

CliniOps completed yet another year of growth, innovation and progress. Looking back, the past year was an exciting year, where CliniOps opened several new relationships and set new targets for ourselves for 2020. The top three areas would be the recognition and interest from the Regulatory bodies (FDA), the Pharma (we are in discussions with some of the top Pharma) and the CRO (we are also in discussions with some of the top CROs). Being a small start-up, getting on the radar of some fo these organizations has never been easy in a conservative industry like the Healthcare and Life Sciences. This gives us renewed excitement and the fuel to accelerate the growth curve. One of the key activity towards that end was our commitment & investment to complete the ISO Certifications: ISO9001 and ISO27001. Quality & Compliance has always been at the core of our culture and will continue to be.

Also, this year, CliniOps founders were invited as Speakers & Panelists at several conferences throughout the year. Several recognitions also came our way, from some of the top Media and Analysts. We hope to continue the momentum and look forward to an exciting 2020 ahead!!

Updates

CliniOps is ISO Certified

Continuing with our focus on Quality & Compliance at the core, CliniOps recently completed the ISO Certifications. Received the ISO9001 (Quality Management System) and ISO27001 (Information Security Management System) certificate. Team CliniOps worked tireless over the past several months to pull this through.

A community mass drug administration for lymphatic filariasis: A multi-center, open-label, cluster-randomized study

One of the early clinical trials conducted on CliniOps mobile eSource platform, back in 2016 just got published on PubMed. We received the protocol with target enrollment of 38,000 patients across 5 countries. But it was very gratifying to see that after enrolling only 26,836 patients the study was stopped as it had hit the desired primary endpoint as per the Biostatistical requirements. This was only possible due to the real-time data analysis from data collected across Indonesia, India, Papua Guinea, Fiji & Haiti – something that was beyond possible back then. Our sincere Thanks to the Gates Foundation and the Washington University School of Medicine, St. Louis for giving us the opportunity to be a part of this great initiative to end Lymphatic Filariasis & Onchocerciasis.

Publication

The Technology Headlines

Yerramalli Subramaniam, CTO, talks about the benefits and challenges of Real World Evidence (RWE) data in clinical trials, May, 2019.

Article

How Kenya’s Fight Against Elephantiasis is Becoming a Blueprint for Africa and the World

It’s very gratifying to see the benefits of our work in action. CliniOps worked with the Bill and Melinda Gates Foundation, to support the clinical trials for the triple drug therapy treatment approach, known as IDA, to cure Lymphatic Filariasis (LF). Based on the results of the trials, World Health Organization (WHO) made recommendations to implement the same globally. Here is a story from Kenya. April, 2019.

Article

Innovation That Matters

Electronic Patient Reported Outcome (ePRO)

Electronic Patient Reported Outcome (ePRO) employs technology such as smartphones, tablets, and personal computers to allow patients, and/or their caregivers to directly report clinical data. ePRO produces highly accurate data that allows for a better understanding of the patient experience in clinical trials and ultimately helps simplify the path to approval. In today’s world, patients usually have one or more electronic devices with them. By collecting ePRO data on these familiar electronic devices, you increase your chances of gathering complete, accurate and timely information in your clinical trial.

ePRO helps you collect timely, reliable and comprehensive data during every trial phase. Better data means a more accurate interpretation of study results and a deeper understanding of your patients. When trying to define ePRO, it’s important to consider its biggest advantage: it’s intelligence. Accelerate your trials by implementing CliniOps’s cutting edge ePRO solution, in either a provisioned or BYOD model.

Conferences

SCDM Annual Conference, 2019

Yerramalli Subramaniam, CTO, invited to speak at the SCDM Annual Conference. He spoke on the topic ‘To Assess Acceptability, and Feasibility of Utilizing the eSource in Comparison with the Traditional EDC Workflow’. Baltimore, September, 2019.

Session Details

FDA Innovation Summit, 2019

Yerramalli Subramaniam, CTO, invited to speak at the FDA Innovate Now Summit at the FDA Headquarters. Washington DC, July, 2019.

CliniOps was one of the select few innovative startups invited at the Summit. CliniOps presentation on ‘Data Science for Life Science‘ for Digital Trials, leveraging AI, Mobile, Analytics, Cloud, Sensors & Connected devices, was very well received. We had Dr. Amy Abernethy (Deputy Commissioner, FDA) and Bakul Patel (Director, Digital Health, FDA) among many others in the audience.

Event Details

IIT Bay Area Leadership Conference, 2019

Avik Pal, CEO, invited to speak at the IIT Bay Area Leadership Conference, 2019 on a panel titled ‘Healthcare and Medicine Through Large Scale Data Analytics’. Santa Clara Convention Center, June 15, 2019.

Panel Details

DIA Global Annual Meeting, 2019

Avik Pal, CEO, invited to speak at the DIA Global Annual Meeting, on the following two panels. San Diego, June, 2019.

Clinical Research in Emerging Regions
eSource and the Sites: Have they Bonded?

We also had several interesting meetings with potential partners, customers and Top Life Sciences Analysts, throughout the week.

Panel Details

Awards & Recognition

Best Poster Presentation Award, SCDM, 2019

There were about 50+ papers submitted to SCDM at this year’s annual Conference, and only eight were invited to present at the conference. Subbu’s paper on ‘To Assess Acceptability, and Feasibility of Utilizing the eSource in Comparison with the Traditional EDC Workflow’ was awarded among the top 3 posters. Baltimore, September, 2019.

Poster Presentations

Red Herring Top 100 North America, 2019

CliniOps received the Red Herring ‘2019 Top 100 North America’ award, as one of the select few startups from the Digital Health domain San Diego, May 2019

Press Release

Publications

Endocrinology, Diabetes and Metabolism Journal (ISSN: 2002-7354)

A paper published by the ‘Endocrinology, Diabetes and Metabolism Journal (ISSN: 2002-7354)’ for a study supported on the CliniOps Data Science system. This is a double-blind, two-arm, multi-centre placebo controlled randomized, Type 2 diabetes trial with two sites: Mazumdar Shaw Medical Centre and KRM Hospital. The trial was designed by Department of Clinical Research at Narayana Health, in collaboration with St Johns Medical College and Boston Children’s Hospital, Boston, MA.