Wednesday, September 15, 2010

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

Friday, September 10, 2010

Where is the foresight ! Why Sponsors must look beyond ePRO?

With the advent of technology and access to internet, there has been a plethora of changes happening across industries. The life sciences and clinical trials not an exception to it, have also been drastically affected by the features of the web and the applications that reside on it.

Until very recent times, patient information capture in the life sciences and clinical trials area was being done through paper (PRO) and the industry has kind of become used to the process of using paper to gather information, peruse it, comprehend and derive results. With risks of incomplete data, illegible handwriting, non compliance of medication intake and the parking lot syndrome, the whole idea of research was going for a toss. In addition to a whole lot of monetary outflow and inconsistent data, the tracking of patient’s medication regimen was getting severely affected. Although to the rescue came the electronic format of the PRO, better known as the ePRO - brining in radical changes in the quality and consistency of data, a major lacunae was seen in untimely medication intake by the patients. Sponsors, CROs and their vendors have been struggling to ensure that their patients are in the closest compliance with the guidelines of the trial to give the most optimum results. No doubts about the fact that the overall performance of the trials per say has got better with patients getting more and more techno-savvy and aware of technological development around them. All said and done – the ePRO and EDC have created magic for the clinical trials and medical research domain- but what now? Are we getting stagnant here? Is not any one looking ahead of time… Has not any one thought of the thing that you can't live with out anymore.. Your Cellphone or mobile phone !!

Mobility solutions for Life sciences and healthcare, better known as mHealth is going to be the next big thing... And some of us just know how big it is going to be

Institutions like that of DIA, FDA, mHealth Alliance and WHO must look ahead to make use of the vision and revolution that mobile technology for health care ( mHealth) or life sciences can bring in…

My indication here is towards the fast developing mobile technology and a foresight to take advantage of it in terms of:
1. The pace of mobile technology development
2. Modes of quick communication
3. To get better in terms of compliance, quality and research results
4. People across the globe keeping themselves abreast with the changing times and technology
5. The world getting smaller
6. The MOBILE REVOLUTION in Life Sciences and Medical Research
7. Mobile Healthcare -mHEALTH

Wednesday, September 8, 2010

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 !!