Monthly Archives: January 2013

Inflamax Research Introduces Electronic Patient Data Acquisition Tablet™ (ePDAT)™ for Real-Time PRO Data Collection

Inflamax Research today announced the introduction of its electronic Patient Data Acquisition Tablet™ (ePDAT)™ which not only facilitates, but also standardizes Patient Reported Outcomes (PRO) data collection across multi-center clinical trials. Pharmaceutical sponsors, clinical researchers and patients now have a significantly improved user experience, accuracy and quality in collecting patient reported data for clinical trials.

Toronto, Ontario (PRWEB) January 30, 2013

PRO data is recognized by most regulatory authorities including the FDA and EMA as important and acceptable endpoints in clinical studies. PRO have historically been recorded on paper diaries requiring subsequent transcription which can introduce human error, data queries and time delays. Its electronic format (ePRO) offers many inherent benefits including increased quality and reduced time to database hard lock. Due to legacy software issues and logistics, this tablet-based technology has not been available from other vendors. Inflamax has devoted considerable time and resources to develop its ePDAT™ system to improve user experience, accuracy and quality, while ensuring compliance with FDA and EMA requirements for validated ePRO data collection tools. ePDAT™ is fully CFR21 part 11 compliant.

ePDAT Detailed ProspectusAttachment
ePDAT Detailed Prospectus

 

“Although ideal for any type of PRO data collection, the ePDAT™ is the first ePRO system specifically designed to meet the needs of allergy and asthma clinical trials as well as Environmental Exposure Chamber (EEC) studies. Data can be collected in the EEC and at home with ease. Our validation studies have shown an enormous preference to using this system versus the traditional paper diaries. We are excited to have this technology available for our upcoming EEC and field hybrid studies. This is the first ePRO system that is capable of next-generation e-data acquisition including geo-positioning, Intelligent Follow-on™ questions and Smart Compliance™ measures built into the base software.” says Dr. Piyush Patel, CEO of Inflamax.

Time point questions appear on the screen in multiple formats.

Time point questions appear on the screen in multiple formats.

The validated ePDAT™ system provides a graphical user interface via a touch screen tablet computer designed to provide a vastly improved user experience. PRO data can be collected by a number of methods which include on-screen questionnaires, visual analog scales (VAS), response time, coordination tasks, high resolution image capture and evaluator interview via video conferencing. Security features include unique password and free hand signatures. Improved software architecture allows patient data to be recorded in real-time directly via the tablet’s cellular wireless connection to our secure database servers. The data are also stored locally on the tablet as back-up. Hard locked data in any format required by the client is available as soon as the last subject is completed.

loginScreen

Users Login with unique User ID and Password

Inflamax’s Smart Compliance™ system incorporates built-in compliance feedback involving the Inflamax Compliance Team communicating real-time with enrolled subjects via push messages, text messages and video or audio links. Compliance enhancing initiatives including newsletters can be pushed to the tablet as needed. Studies have shown that such enhanced compliance measures significantly improve the compliance and quality of data collected in clinical

questionScreen

Questions can be pushed to the user at timed intervals

trials. Intelligent Follow-on™ allows for protocol-specific, pre-programmed and approved, follow-on questions to be posed based on previous responses for PRO and adverse event data collection.

The ePDAT™ system was developed in partnership with Logos Technologies, the leaders in early phase data acquisition technology. The Inflamax phase one unit already has ALPHADAS,

ePDAT Visual Analog Scale Interface

ePDAT Visual Analog Scale Interface

Logos Technologies’ pre-eminent eSource bedside EDC system, enabling paperless phase I studies that deliver real time ‘report ready’ data. ePDAT™ integrates with ALPHADAS to ensure seamless data delivery for Inflamax sponsors and partners.

 

 

 

About Inflamax

Inflamax is a full service Contract Research Organization (CRO) specializing in Proof of Concept as well as Phase I through IV studies in allergy, asthma, ocular and dermatology utilizing EEC technology. Inflamax conducts single and multi-center Environmental Exposure Chamber (EEC) and field studies. In addition to Inflamax Research’s Mobile EEC™ systems which can be positioned globally, Inflamax has 2 fixed EECs at Inflamax headquarters in Toronto, Canada. Inflamax’s EECs have been validated for study of allergy to ragweed and grass and also for the study of dry eye syndrome (utilizing low humidity EEC conditions). Validations are currently in process for cat and dust mite allergens and are expected to be completed in Q1’2013, thereby making the EECs suitable for clinical studies to test medications for perennial allergies.

About Dr Piyush Patel

Dr. Piyush Patel, Inflamax’s CEO is an industry veteran who has been in the forefront of development in EEC technology. Dr. Patel is an author of several patents relating to EEC technology and has been involved in the development of many mainstay anti-allergy drugs and immunotherapies currently on the market. He was the owner of Allied Research International; a CRO specializing in EECs, which was sold in 2007. Dr. Patel was also named Entrepreneur of the Year in 2008 for his work in building that company.

Inflamax Research announces the launch of its Next Generation Mobile Environmental Exposure Chamber™ for conduct of Allergy & Asthma Trials

January 17, 2013; Toronto, Ontario, Canada – Inflamax Research, announces the development and validation of a unique Next Generation Mobile Environmental Exposure ChamberTM (EEC) system, which enables the pharmaceutical industry to perform single or multi-center EEC clinical trials in any location worldwide.

Attachment
Mobile Environmental Exposure Chamber (EEC) Detailed Prospectus

EEC technology is a clinical model that greatly enhances the sensitivity and specificity of pivotal clinical studies required for FDA drug registration. The Next Generation Mobile EEC technology consists of transportable clinical facilities to perform controlled allergen exposure; allergic subjects sit in a validated environment room and are exposed to a controlled level of airborne allergen. Subjects exposed to allergen in this environment develop allergic symptoms in a known, predictable manner. The subjects are asked to record instantaneous symptoms on a diary card. The resulting data are far superior compared to traditional methods of evaluating anti-allergic drugs in development.

Inflamax Research's Mobile EEC

Inflamax Research’s Mobile EEC

“Up to now EEC studies could only be performed in a single center setting within a fixed EEC site. This has limited the usefulness of this powerful technology to small, single center studies in one geographic location. There have been major challenges in recruiting specific types of subjects for these studies due to the limited volunteer pool locally, as well, the available volunteers have already been treated with immunomodulators which in some cases, excludes them from participation in future studies. With the Next Generation Mobile EEC system and expert clinical Investigator consortium, we can now go to geographic locations where the volunteers are. With the availability of Inflamax’s Next Generation Mobile EEC system, we have noticed a significant decline in the interest in conducting fixed single site EEC studies from our clients in favor of the multi-center EEC approach.” says Dr Piyush Patel, CEO of Inflamax.

Inflamax has developed a network of Investigators in North America and Europe who will participate as sites to recruit subjects in diverse geographic locations for multicenter EEC trials. These investigator sites can recruit specific populations from their databases. With the availability of the Mobile EEC system, the potential pool of subjects is vastly increased.

“Our Next Generation Mobile EEC system provides the ability to utilize identical EECs in multiple locations.  FDA has indicated that such a standardized EEC system would be required for pivotal multi-center EEC trials. We are working with clients on several hybrid field-EEC study designs that incorporate EEC exposure with traditional field study design, the first of these studies is slated to start in the next few weeks” says Dr. Piyush Patel.

About Inflamax

Headquartered in Toronto, ON, Inflamax is a full service Contract Research Organization (CRO) specializing in Proof of Concept, and Phase I to IV studies in allergy, asthma ocular studies and dermatology. Inflamax has unique electronic data collection tools for single and multi-center EEC and field studies which greatly improve the quality and speed of data collection in clinical trials. In addition to the Next Generation Mobile EECs, Inflamax has two Next Generation EECs fixed in place at Inflamax headquarters in Toronto, ON.  These EECs are already validated for Ragweed, Grass and Dry Eye (low humidity).  Validations are currently in process for cat and dust mite allergens.

About Dr Patel

Dr. Piyush Patel, Inflamax’s CEO is an industry veteran who has been in the forefront of development in EEC technology. Dr. Patel is an author of several patents relating to EEC technology and has been involved in the development of many mainstay anti-allergy drugs and immunotherapies currently on the market.  He was the owner of Allied Research International; a CRO specializing in EECs, which was sold in 2007.  Dr. Patel was also named Entrepreneur of the Year in 2008 for his work in building that company.

For more information contact:
David Selkirk / Karen Shields
Director, Clinical Trial Management / Senior Director, Operations
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