Cloud-based eClinical Systems – Myths, Challenges & Opportunities

Al Gicqueau, CEO & President at Clinovo talked about Cloud-based eClinical Systems to make clinical trial process more efficient and cost-effective, at www.bio2devicegroup.org event.

Cloud has been a big buzz word, significantly impacting the economy, in the last few years.  Cloud is growing 3X faster than traditional internet infrastructure, said Gicqueau.  Worldwide public cloud services market will total to over $73 billion, by 2017.  There is also simultaneous cloud-bashing.  According to Citrix research, majority of the Americans don’t understand it and over 51% think it has something to do with the stormy weather.  Most also believe they have never used it but over 95% of us have used cloud based services.

It is therefore important to understand what constitutes cloud based services.  There are 5 essential components of cloud based services.
Self Service, On Demand: Cloud based services are available, when the consumer needs them.  Further, for the most part  they are autonomous and the user can perform the actions without going through the IT department.  They are easy to use and on-site training will increasingly become a thing of the past.  Any training required has to be available on-line and has to be very short and for the most part the service has to be intuitive and should not require training.
Broad Network Access: Cloud based services provide a broad internet access.  For instance, consider gmail.  It can be accessed through desktop, laptop, tablet, smart phone etc.  Cloud based services enable an ability to easily synchronize information over multiple devices.
Resource Pooling: Amount of traffic over the internet is rapidly growing. Because of the distributed nature of the internet, there is no single point of measurement for total internet traffic.  But it is a fact that the total global IP traffic will pass the zettabyte threshold by the end of 2015.  By the year 2017, the total internet traffic is expected to reach 5.3 zettabytes.  To put it in perspective, if the 11 oz coffee on your desk equals one gigabyte, a zettabyte will have the same volume as the great wall of China!  Cloud based services enable customers to pool their resources and save cost.

Rapid Elasticity: In the world of internet activity there are lot of peaks and valleys.  Cloud can scale based on demand peaks, without incurring penalty for the period of low traffic.
Measured Service: Cloud offers and ability to pay as you go.  People can pay for the internet infrastructure as they pay for electricity.
Some of the examples of cloud based services include, SalesForce, Netflix, Gmail and Amazon.

Clinical Data Trends

Spiraling costs have been a grave concern in healthcare.  Typically, efficiency has not been very high in the area of healthcare. Costs of clinical trials is likely to increase even more significantly, in future, on account of increasing costs of medical research and changing and tightening regulations, among other things.  Increased costs for clinical trials will push the cost of drugs higher.  On the other hand, there is strong public criticism of higher costs of medicines and there is a lot of pressure on drug companies to contain costs.  Companies have pressure to cut the middle layers and manage clinical trials on their own.  Citing CISCRP (Center for Information & Study on Clinical Research Participation) study, Gicqueau said, currently, only 6% of clinical trials are completed on time, whereas 72% run late by over a month.

Compliance issues and regulations specified in 21 CFR, part 11, prohibit use of public cloud, for clinical data.  Clinical data has to be stored in a private cloud.  Clinovo’s ClinCapture is a cost-effective EDC (electronic data capture) system.  It is tailored to specific clinical studies teams and offers intuitive navigation and one-click access to routine functions.  It reduces time for data entry.  ClinCapture is also flexible and can be customized and deployed rapidly.  “We validate our software like medical devices are validated”, said Gicqueau.

Mobile is next major trend, as more data entries are happening through tablets and smart phones.  Tables are also very useful in remote regions of the world where cell phone reception may be spotty or non existent, where information can be easily synchronized later.  Data entries can also be structured  by getting patients involved.  Data integration is another big challenge.  Everyone hopes to make sense of the data and make meaningful use of the data.  However, making sense of the data and putting it to good use remains expensive.  Gicqueau said, meaningful data integration is another promise of the cloud.

Clinovo is launching CloudClinica, next generation, cloud-based eClinical platform.  With its easy to use, pay as you go platform, CloudClinica will eliminate IT dependency and allow small companies  to manage clinical studies in a sophisticated manner, without high level programming skills.  About 30% of cost and 60% of time associated with clinical trials is about data management, and almost 80% of clinical trials are still conducted on paper, said Gicqueau.  Paper has many pitfalls.  Paper can get lost, it is inefficient, there is challenge of mis-reading someone’s handwriting, it has regulatory risks and other hidden costs.  CloudClinica is FDA compliant and it can scale.

Clinovo had revenues of over $4 million in 2013 and raised $500,000 from business angels over the last few months to execute on their business strategy.   The company is profitable, and has 30+ clients that include Gilead, Roche and others.  Clinovo is now targeting small to mid-size companies, said Gicqueau.  Current market of $2.3 billion can be rapidly growing in the coming years.  MediData and Oracle are two dominant players but are relatively more pricey.    Clinovo’s CloudClinica will fill in the gap and broaden the use of eClinical systems and will empower and bolster the biotech, pharmaceutical, and medical device companies, said Gicqueau.  The event was followed by Q&A.

Jobs – January, 2013

Guidewire ClaimCenter Professional –  (location – Washington DC).

This is a one year contract opportunity.

SOA Engineer Lead Role – Tampa, FL – 1 year duration

There is an immediate opening at Tampa, Florida location for SOA Engineer for 1 year duration contract work.

Skills required: Very strong knowledge in WebLogic 10.x/11g and FMW space, Strong knowledge Oracle SOA10g/11g & OSB11g implementation/administration, Experience with all out of box technology adapters (Apps, DB, MQ, JMS, File, FTP, etc.) and configuration, Experience with Oracle OAS10g, BPEL, OHS, OWSM, SSL strategies, Linux, Unix, Windows Server, AS400, z/OS, Oracle OEM11g/12c, IBM Tivoli, Subversion, SQL, Visio, Oracle SOA/ESB development skills a plus but not required, Scripting knowledge (WLST, ANT), JVM monitoring/tuning experience, Performance monitoring and tuning, Strong communication skills.

Job responsibilities include: Architecture planning and design for all related components, Evaluate project proposals and estimated related labor to implement, Installation and configuration for environment builds including post build expansion, Product patching and analysis for implementation, Capacity planning and scaling analysis for all components, Create and maintain documentation as needed for future reference, support turnover, etc., Present topics of interest for team knowledge and review related to ongoing initiatives, Participate in knowledge transfer for level 1/2 support teams, Performance monitoring and identification of related issues, Manage engineering service requests and defects, Support code migration, automation and troubleshooting, Engage with other IT tech teams and request systems for troubleshooting or infrastructure dependencies related to project task completion, Provide guidance for Level1/2 teams as relates to their assigned tasks, Initiate, communicate and drive production changes via formal change management system, Take ownership of assignments and drive them to conclusion, Initiate vendor support requests and keep momentum for conclusion, Implement monitoring solutions as needed for existing or new components, Implement automation solutions for repetitive tasks where appropriate, Participate in 7×24 on-call rotation support for production.

Oracle SOA Architect – Herndon, VA, – 1 year Duration 

There is an immediate opportunity for Oracle SOA Architect at Herndon, VA for 1 year duration contract job.

Skills & experience required: Min 10 years of experience in Software Design/Development, Project experience in designing and implementing Oracle SOA suite components, Experience in the design/ implementation of technology infrastructure and architecture blueprint including Oracle Fusion Middleware, Must have experience as an SOA Architect /Tech Lead in delivering at least two SOA Enterprise-level Projects including at least one involving legacy mainframe systems, Hands on experience in SOA analysis/planning, Service Modeling, Business Process design, SOA Composition, SOA Governance etc., Strong Java/JEE development experience, specifically in regards to deploying applications, leveraging AIA patterns and experience in architecting SOA-based solutions, Proven project experience with hands-on development and configuration experience in Oracle JDeveloper 11g with strong BPEL design/development skills, Technical know-how on and hands on experience in designing a SOA governance framework using Oracle SOA products, Excellent written and verbal communications skills, Experience with UML. Knowledge of design patterns.

Required Tech skills: OSB (Oracle Service Bus ), Oracle Mediator, BPEL Process Manager, Oracle BPM(Business Process Manager), Oracle CEP (Complex Event Processing), Oracle Policy Manager, Metadata Service Repository, Oracle Business Activity Monitoring, OEM (Oracle Enterprise Manager), Oracle Adapters, Oracle Business Rules, Oracle User Messaging Service, JDeveloper , Java, J2EE, Web Services , SOA, REST , XML /XPath / XQuery / XSLT, Any recent versions of Oracle Database.

Seeburger Architect – Hartford, CT, 1 year duration

There is an immediate opportunity for Seeburger Architect for 1 year duration at Hartford, CT location.

Skills & requirements include: Should have architecture and design experience, Should know the pros and cons of various B2B products vs Seeburger BIS 6 and BIC 6, Should have work experience in BIS6 and migration, Should be well aware of communication protocols and transaction standards, Should have worked in Business process implementation and testing using BIS6 process designer, TP setup and mapping experience using BIC6 Mapping designer, Should have good communication skills, Should have onsite –offshore and SDLC work experience.

Analog Design Engineer –  Sunnyvale, CA

A Contract Engineering company located in Sunnyvale, CA has an immediate part-time contract opportunity for Analog Design Engineer, that is likely to become permanent in 3-6 months. Minimum 10 years of experience with analog circuit design, including amplifiers, ADCs, power supplies, and sensor signal conditioning is required. Also required, experience with digital design and ability to work with digital engineers to develop successful integrated products. Experience with signal integrity and/or RF design a plus.

The person must work well on a team, have good communication skills, and be able to adjust quickly in a fast paced environment where many designs are done simultaneously. This is a challenging and rewarding opportunity for the right person.

Clinical Data Manager – Redwood City, CA

There is an immediate opening for Clinical Data Manager for San Carlos, CA based medical device company. Responsibilities include, design, develop and enhance clinical databases and data reports and perform validation of databases and reports to ensure data accuracy, completeness and integrity of data entry, discrepancy database management, study documentation and data auditing. Job functions include, participating and providing support for data management activities, investigator meetings, DSMB meetings and regulatory submissions, assisting study team with the preparation of data collection forms and charts for the reporting of research data, supporting international and FDA regulations and company goals, policies and procedures, and complying with Quality System.

Requirements include, knowledge in regulatory requirements, FDA, ICH, GCP etc. guidance, experience using Commercial Off the Shelf Clinical Data Management and/or Electronic Data Capture products (e.g. Clindex, Oracle Clinical, Phase Forward, eTrials, etc.) is required. Experience using relational databases (e.g. MS SQL Server, MS Access, or Oracle) is a plus. Also required, a Bachelor’s degree in related field with minimum 3 years experience in clinical data management supporting clinical trials, including experience in regulatory submission of drugs or medical devices.

Sales Rep – Los Angeles, CA

This position will play a visible role in drug rep industry, by developing critical relationships, primarily with doctors of many disciplines to share the availability of breakthrough pharmaceutical grade pain management option that would diminish pain, aid in sleep, and enhance quality of life as a holistic alternative to addictive and sometimes life threatening drugs. Specific responsibilities will include, provide field based scientific exchange and communication regarding the product, broad interdisciplinary background and proven ability to establish relationships with doctors across variety of disciplines, tenacity and drive to reach out to new doctors, and ability to work the referrals, and to network and partner with medical practitioners. Requirements include, pharma or medical industry sales background, strong sales success track record, consummate professionalism including understanding of sensitivity of subject along with ability to deal warmly with high powered, industry-leading medical professionals, strong entrepreneurial spirit and passion for the vision of managing pain with a holistic alternative. This position is located in Los Angeles, CA.