PaDiSys-mPRO and PaDiSys mTA

PaDiSys mPRO and PaDiSys mTA is the next wave in the clinical trials industry. Using the power of mobile phones to keep patients enrolled in clinical trials compliant to the trial protocol is the idea behind this initiative. Taking clinical trials to the next level from Paper PRO to ePRO to the present generation techniques of mPRO, the PaDiSys Solution is going to make things easy for every one participating in the trial.

The PaDiSys Solution allows Clinical Staff, Sponsors and CROs to monitor patients through a synchronized mechanism between the mobile phone being used by a patient and the web interface provided to them.

PaDiSys solution has been built from ground up following international development guidelines such as the GAMP 4/5 and regulatory guidelines such as that of FDA, EMEA, 21 CFR PART 11 etc.

The solution brings the following features to be used in a clinical trial:

** Medication Intake Adherence

i. Medication Intake Reminders

ii. Medication Intake Alerts

iii. Medication Intake Follow-up

** Site Visit Adherence

i. Site visit Reminders

** Miscellaneous Reminders

i. Blood Draw

ii. Blood Pressure Check

iii. Blood Sugar Check

iv. Instructional or Intervention messages

** Localization capability for patient's compatible mobile devices

** Real time - Patient wise Trial adherence monitoring system - Web interface for Site Investigators and Clinical Staff

** Reports and Analytics on various parameters

** Multilingual Support / Call centre

mHealth in Emerging countries - Going beyond general healthcare !!

The rapidly increasing numbers of mobile phones and its users across the globe are opening up an all new dimension of providing better healthcare. While the developed nations are enjoying the perks of high end technology reaching out to them,it is a growing concern for those in developing or emerging nations to be matching the pace at which the other world is going.


Mobility Solutions for emerging nations is the next big thing that us in the Mobile Health Care industry need to think of. There are people who have been thinking and to an extent been acting up on it, but to actually bring it on to the table it will need some really user friendly products/services that would enable people/patients from all walks of like and socio-economic strata to have access to these facilities.


Unlike the western nations with advanced technology as a part of their dailies, we would need to bring out solutions that are not device specific but are generic and can be used by absolutely every one !!


NowPos from India (www.nowpos.com) certainly has made a point here by introducing such features for a developing or emerging nation by taking the lowest denominator of all phones and providing absolutely what other high end devices are providing. The solution introduced caters to Treatment Adherence, Patient reported outcomes, Electronic Health Records (EHRs) , Medical Health Records (MHRs), Patient care, Post discharge care and many other spheres for multiple therapeutic areas.


We need to take a few concrete decisions and steps to notice and provide the best that we can using the available technology.


Cheers !!

Clinical Trials - Yet another part of mHEALTH

Clinical Trials may be defined as voluntary research studies, conducted in people, that are designed to answer specific questions about the safety and/or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments. (Courtesy: FDA). Clinical trials have been existent since eleventh century wherein the learned lot of those times tried, tested and laid regulations for experimental use and testing of drugs and other related substances. Today in the 21st century, we have a whole population across the globe working on prevention and cure of diseases with latest technologies and science in a regulated environment put down by governing authorities and bodies like FDA, HIPPA, CDISC and others.

Clinical Trials can be classified into:
1. Observational Study
2. Interventional Study

There are different types of Clinical Trials specified by US NIH (National Institute of Health) as:

1. Prevention trials: look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.
2. Screening trials: test the best way to detect certain diseases or health conditions.
3. Diagnostic trials: conducted to find better tests or procedures for diagnosing a particular disease or condition.
4. Treatment trials: test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
5. Quality of life trials: explore ways to improve comfort and the quality of life for individuals with a chronic illness (a.k.a. Supportive Care trials).
6. Compassionate use trials: provide experimental therapeutics prior to final FDA approval to patients whose options with other remedies have been unsuccessful. Usually, case by case approval must be granted by the FDA for such exceptions.

The clinical trials process may be categorized into four major phases namely:
1. Phase I - Phase I trials are the first stage of testing in human subjects.
2. Phase II- Once the initial safety of the study drug has been confirmed in Phase I trials, Phase II trials are performed on larger groups (20-300) and are designed to assess how well the drug works, as well as to continue Phase I safety assessments in a larger group of volunteers and patients. When the development process for a new drug fails, this usually occurs during Phase II trials when the drug is discovered not to work as planned, or to have toxic effects.
3. Phase III -Here studies are randomized controlled multicenter trials on large patient groups (300–3,000 or more depending upon the disease/medical condition studied) and are aimed at being the definitive assessment of how effective the drug is.
4. Phase IV - Phase IV trial is also known as Post Marketing Surveillance Trial. Phase IV trials involve the safety surveillance (pharmacovigilance) and ongoing technical support of a drug after it receives permission to be sold.

Well, this is just a brief overview of what can be a Clinical Trial. It would come as an astonishing fact to those who are looking at it for the first time... This industry is typically conservative and a lot of people do not know what actually goes behind the scenes while making a drug. This industry is regulated by major regulatory and compliance authorities. There are a lot of other interesting things that make this a booming sector - EDC - Electronic Data Capture, ePRO- Electronic PRO, mPRO- Mobile PRO, about which I shall discuss in my forthcoming blogs.

Happy reading !! :)