Deal Radar - CliniOps, Fremont, CA

Due to the complexity of clinical trials and their outdated systems, it takes more than 12 years and $2 billion to bring a new drug to market. CliniOps is a leading mobile, cloud-based, digital solutions company that leverages Social, Mobile, Analytics, and Cloud to help the Pharma, Biotech, and Medical Device companies bring drugs and devices faster to market, with high data quality and less cost. The company has already crossed the $1M in annual revenue milestone and forecasts $3.5M in 2018.

Avik Pal, Founder and CEO of CliniOps, was introduced to the challenges in clinical trials by his physician wife who was involved in running clinical trials in a San Francisco-based research center. Avik also volunteered in a few of the clinical trials to better understand the process. He soon realized that most clinical trials are very global in nature in order to tap into a heterogeneous mix of patient population. However, these global trials faced challenges in data safety, security, compliance, management, and analytics. Although existing Electronic Data Capture Systems (EDCs), such as Medidata Rave and Oracle InForm, have improved the data collection process to some extent, Avik identified several gaps between these solutions and the increasing demands of the industry to reduce time and cost and improve data quality.

Avik, a graduate of Indian Institute of Technology (IIT), then founded CliniOps in October 2013. Prior to that, he had worked for over a decade with two successful startups in the enterprise applications space. He was joined by CliniOps co-founder and CTO Yerramalli Subramaniam, also an IIT graduate, who had worked with Sanofi, Life Technologies, and Thermo Fisher in the past. He had launched several products in the medical device and gene sequencing space and is the primary architect of the CliniOps eSource solution. Later, Partha Chakraborty joined the team to help drive global delivery. Prior to joining CliniOps, Partha was the Global head of Cognizant Life Sciences, and also held the position of Chair, CDISC AP3C (Asia Pacific Coordination Committee), a key industry forum working on data standards in global clinical trials. The deep domain knowledge in the team has helped the company achieve product-market fit without any external financing.

Over 50% of the EDC market is currently dominated by Medidata and Oracle. They offer very complex systems that are primarily adopted by big pharma companies. Some major drawbacks of these solutions are the need for Internet at the point of care, complicated user interface, need for extensive training. Most sites go with a Hybrid process where data is first captured on paper and then transcribed into the system. There is thus a high reliance on source data verification (SDV) and the source documents need to be archived in a compliant way for several years even after the study is completed. Study Monitors travel to study sites around the world to manually verify the accuracy of the data entered against original data sources in order to maintain regulatory compliance. This effort, called SDV, accounts for more than 30% of clinical trial time and costs. Thus, in spite of incurring all expenses of EDC systems, the Pharma and Biotech companies are deprived of the full benefit of this technology.

Due to the portability and ease of use in busy clinical environment, newer tablet-based EDC systems are fast gaining popularity. However, the major tablet-based EDC systems in use today, such as BioClinica’s Express EDC and Medrio, mostly support online data capture and hence are restricted to areas that have reliable Internet availability. Although ClinicalInk does support offline data collection using digital ink and tablets, it is heavily dependent on handwriting recognition technologies.

To address these challenges and gaps in the market, CliniOps leap-frogged to a tablet-based eSource solution called CliniTrial, which is compliant with regulations and supports offline data collection through its patent-pending technology. CliniTrial is a highly user-friendly hand-held system that is compatible for use in a busy clinic environment. It enables automated electronic data capture at source through innovative features such as medical device and software integration. These, coupled with powerful point-of-care edit checks, drastically increase data quality. CliniTrial also has the provision for biometric registration, electronic informed consent, and several other integrations that not only eliminate inefficiencies and manual processes, but also transform the clinical trial workflow by streamlining data collection, analytics, and submission processes. BioTech companies or sponsors also get instant visibility of study KPI’s, with real-time reporting/analytics, and other rich capabilities. CliniOps is also developing real-time decision support systems using artificial intelligence and machine learning.

Compared to its competitors, the CliniOps solution has significant advantages in resource poor settings. Thus, the initial traction came from studies where at least a few sites were in the emerging world countries. CliniOps’ solution is currently used in over 15 countries across North America, South America, Asia, and Africa, with over 50,000 patients on the platform. The current customer base includes several Pharma, BioTech, and Med Device companies. Some of the supported trials have gone through FDA submissions, and others are in progress. The company is also working with top-tier academic institutions and global health foundations to support clinical research, some of which has been submitted to the WHO and has been published in top-rated journals.

CliniOps has received many industry recognitions and awards from Frost & Sullivan, Everest Group, PharmaVoice, ComputerWorld etc., and its founders were invited as speakers/panelists at GES, DIA, SCOPE Summit, Health 2.0, TiECon, and other conferences.

The eClinical Solutions Market is currently estimated at $7.6 billion, growing at 12.4% CAGR. About 12,000 new trials are run every year. The CliniOps pricing model is based on the study Phase. A typical Phase 1 study deal size is about $100K, whereas a Phase 3 study is usually over $1M. As part of its customer acquisition strategy, CliniOps has established a few channel partnerships with multi-billion SIs with a large focus on Life Sciences and with a few small contract research organizations (CROs). CliniOps is also in discussion with a few large CROs to help gain a wider adoption.

CliniOps is headquartered in Fremont, CA, USA and has an office in Kolkata, India. It has bootstrapped so far and grown to a 15-member team through customer revenue. CliniOps ended 2017 with over $1 million in revenue. It has already signed contracts of $750K+ for 2018 and the projected revenue target for 2018 is $3.5 million. CliniOps is now seeking a $5M investment to scale the company to the next level.

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