Newsletter: 2016 Oct

Welcome to our first quarterly newsletter designed to help you stay on top of changes in the Clinical Trials eSourcing Industry

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The Beginning

Simple ideas have the power to make an impact in the world. About 3 years ago, while having lunch in a little Thai restaurant in downtown San Francisco, Avik Pal, Founder of CliniOps, was chatting with a few scientists about the antiquated practices that are in place for data collection/management in clinical trials. Despite the massive digitalization in other industries, clinical trials processes remained heavily paper based. Avik was quick to realize the potential of leveraging cutting edge technology such as Social, Mobile, Analytics & Cloud (SMAC) in order to bring about transformation in the clinical trial industry and disrupt its age old data management process. The idea immediately struck a chord with several other professionals plugged into the clinical trial ecosystem. Avik and his partner, Yerramalli Subramaniam founded CliniOps – a company with a vision to completely digitalize the clinical trial industry.

CliniOps Traction

We are currently serving several customers, that touches 50,000+ patients and spans across 10+ countries.

Currently supporting Trial Sites in USA, Africa & Asia

A large Global Health Foundation: CliniOps solution was selected among several other eSource/EDC providers to support a 36,000+ patient study, on Lymphatic Filariasis, across 6 countries – Fiji, Papua New Guinea, Haiti, India, Sri Lanka & Indonesia. Most of these locations have a wide range of operational challenges such as lack of access to internet at the point-of-care, dearth of computer literacy of nurses/healthcare-workers, various cultural challenges of data collection, regulatory hurdles et. al. CliniOps was able to address all these challenges and configure the system to the satisfaction of the sponsors.
An Innovative Silicon-Valley based Med Device company: We are not only their data management partner for their 510K submission for FDA approval, but we are also working together to integrate their devices and applications to our system. This will ensure direct transmission of data from their devices to our system without any manual interference. The study is also leveraging our ‘electronic Informed Consent’ (eICF) module to enroll study patients.
Data being collected via tablets at a remote village facility, Yadgir district, India

Data being collected at a community center facility, Phoenix, AZ

A Top Tier Med School: CliniOps is supporting the data management of a global psychiatric trial with sites in USA, Ethiopia and Somaliland. Prior to CliniOps, the trials were being run on a web based EDC platform, which required a heavy reliance on paper at the point-of-care, since internet is not always available where the patient-doctor interaction happens. Hence, time lag between data collection and data readiness was about 90 days. By switching to offline data capture via tablets on CliniOps eSource application, the team was able to bring the delay down to a few hours with a much higher data quality.

Clinical Trial Ecosystem

Alliances/Partnerships:

  1. Product Partnership: CliniOps partnered with IBM Watson to build interesting solutions in the space
  2. Services Partners: CliniOps signed a partnership with a multi-billion $ global services organization, with a heavy Life Sciences focus
  3. Clinical Research Organization (CRO): CliniOps partnered with two CRO’s in India and Europe

News from the Industry:

  1. Commissioner of FDA is passionate to promote quality and efficiency of clinical trials
  2. Bill Gates on what is the most dangerous animal in the world? Nope, it’s not lion, it’s a mosquito.
  3. TransCelerate launches two new initiatives to accelerate clinical trials

India Office

Subbu, with CliniOps India Team

CliniOps opens its first overseas office in Kolkata, India, with a team of Doctors, Data Scientists, Developers, Configurators and Software Quality professionals. The addition of the India team helped CliniOps to accelerate product development and extend customer support to a wider time zone. CliniOps is in active discussions with a few top industry leaders to further ramp up the team.

We are fueled by the energy of our team and the satisfaction of our customers!!

Founders in the News

Avik Pal (CEO) was invited to speak at the DIA Conference, Washington DC, 2015

Yerramalli Subramaniam (CTO) was awarded Computer world’s ‘Premier 100 IT Leaders’ Award, 2015, FL

Awards & Recognitions

DST-Lockheed Martin Innovation award, 2016

PharmaVoice Innovation Issue, 2015

Top Startups in America, 2015

Pushing Innovation In Digital Health, 2015

Editorial Article by CliniOps CEO, 2014

Global Hot Technology Start-up, Santa Clara, CA, 2014

CustomerSpeak

“I have to say that now personally having gone through each and every form on the tablet, I really appreciate what a great system this is and how it will help us to have better data in the long run.”

Vice President for Research, Elizabeth Glaser Pediatric AIDS Foundation

“CliniOps tablet application was very intuitive and a quick onsite training helped our volunteers to record about 200 patient data, in less than 4 hours, without issues.”

Director of Patient Services, National Kidney Foundation

“CliniOps is innovative, easy to use, and has the potential to transform how we recruit and consent subjects. I believe that it is a real innovative improvement in clinical research.”

Chair, IRB, California Pacific Medical Center

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