Villagers in Mali provide information to a field worker implementing the clinical study monitored by Hygiea.The recent hit film The Constant Gardener based on the novel by John Le Carre, is set against the backdrop of manipulated clinical trials for a drug which is being surreptitiously tested on poor villagers in Africa.

According to Dr. Oren Fuerst, the Managing Director of Strategic Models LLC, if the Israeli-developed Hygiea software system for a large clinical study had been implemented, such infractions could never have occurred, and he jokingly adds that Le Carre would have been forced to change the plot.

The Israeli-raised Fuerst is the mastermind behind Hygiea – aptly named after the daughter of the Greek God of Healing Asclepius who practiced in about 1200 BC and who gave the English language the word hygienic.

Fuerst’s Tel Aviv and New York-based company Global Digital Health (GDHealth), recently proved the efficiacy of Hygiea by successfully deploying the software for a large clinical study, funded by the Bill and Melinda Gates Foundation and conducted by the University of Maryland’s Center for Vaccine Development (CVD) in Mali, Africa.

The university initiated the large scale epidemiological research conducted in Mali, to uncover the health trends and impact of new vaccines introduced to the country’s infants. The study will cover more than 100,000 people over a vast geographical area, over the course of three years.

“I’ve been involved in consulting investment in the US, mainly focusing on the life sciences for the last 10 years,” Fuerst told ISRAEL21c. “We established Global Digital Health at the end of 2003 with the goal of creating a highly flexible software platform for the clinical trial arena.
We’ve been working mainly with universities and companies, often in the context of homeland security. For example, we provided the technical infrastructure for the state of New Jersey which surveyed their smallpox preparations.

“And we helped a medical center in Washington DC – which was creating the ’emergency room of the future – in the context of an immunization platform for the rapid response of a flu epidemic, helping to answer the question ‘What happens if they need to administer mass immunizations?'”

Headquartered in New York City with a development center in Israel, GDHealth supports pharmaceutical, diagnostics and medical devices companies, academic research institutions and health agencies worldwide with specialized products and services that meet a broad spectrum of healthcare demands.

Fuerst said that the Mali collaboration with the University of Maryland arose through contacts between himself and Prof. Myron Levine, the director of its internationally recognized Center for Vaccine Development.

“It took some time to get off the ground – and to get the sponsorship from the Gates Foundation, but then things moved very quickly,” said Fuerst.

A full team was sent from Tel Aviv to Mali and has just completed the deployment of the system. According to Fuerst, due to the size of the study, data collection using paper would have made this a prohibitively expensive effort, prone to data collection errors. A technology driven solution was needed, but there was no supporting infrastructure and many of the subjects and staff involved in the data collection had never used a computer before.

Hygiea’s software suite was configured to fit the special data collection flow used in the study. An advanced information-driven medical data capturing and analysis suite of tools which facilitates cooperation within and between organizations and agencies, Hygiea increases the cost-efficiency of routine and emergency processes, and improving patient safety and the quality of patient services.

“The project itself had a few components. Mali is one of the poorest countries in the world, and one of the last countries in the world to introduce vaccines,” explained Fuerst.
“The idea was to check the impact on health care, particularly the situation of infants.

“We did this in a number of ways. Over a three year period, we’re documenting 100,000 people from beginning to end. Another mechanism was a particular hospital – in which every patient is screened and documented. The infants are even more thoroughly probed, as they are the most relevant to the vaccine. And another method is conducting a house to house census – going to their homes and documenting their living environment – if they have running water, and other environmental factors”

“The impact of this efficiency, which facilitates a faster conclusion for a study, is tremendous. As a result of utilizing the tool, new diagnostics, vaccines and drugs could reach the market more quickly, benefiting millions of children and adults worldwide. The tools can also be used to address emerging healthcare needs around the globe, for example, as part of disaster relief efforts in Indonesia and Pakistan, HIV diagnostics and treatment clinics in Africa and Asia, or healthcare clinics and labs in any part of the world.”

According to Fuerst, the big innovation to be derived from the study courtesy of Hygiea is the minimizing of human error due to haphazard data collection.

“This study is paperless. So many mistakes can be introduced transferring data from paper to computer. And it’s not like you can go back to someone’s house who had a 100 degree temperature and take it again because the researcher actually wrote down 300 degrees. Utilizing Hygiea eliminates the unproductive scenario of a researcher receiving illegible information on a piece of paper back at his office, while the subject lives many thousands of miles away and can’t be reached by phone to verify a question. It also allows rapid changes to the information flow and questionnaires to be made by authorized personnel in the field,” said Feurst.

“We realized that a study of this tremendous scope required a mobile computing platform. Instead of relying on paper forms, which could get lost or damaged, researchers and clinicians simply carry the Tablet PC from house to house or health clinics and hospitals, and use the pen to fill in the data fields directly onto the computer. Later the researcher can connect to the Internet and submit that forms through a Web service and Satellite technology back to the research center,” he added.

Among the initial reservations of the project team was how the local researchers in Mali were going to be trained to undertake such a huge endeavor, but Fuerst said that there was a pleasant surprise, which derives back to the Hygiea’s flexibility.

“At first we thought this is going to be horrible. But we went through training and in less than a day, people who had never used computers before were up and running,” he said.

“Among the advantages of Hygiea is the fact that it is a robust and flexible system yet it is very easy to use, features that are crucial in developing countries. It was amazing to see how people that never used a computer before were using Hygiea within a few hours of training,” added Baruch Yoeli, who manages the Israeli Branch of GDHealth and leads the R&D efforts.

Yoeli and Fuerst have spent over three years developing the Hygiea before its deployment. Fuerst holds degrees in economics and accounting (Dual Magna Cum Laude) from Tel Aviv University, and his master’s and Ph.D. are from Columbia Business School. He was a faculty member of the Yale University School of Management and served in the elite technology unit of the Israel Defense Forces (IDF). He has more than 15 years of experience in venture, technology development and investments.

“Soon after September 11, we began to get more involved in homeland security in regards to health care – like how to plan for an anthrax attack. After the anthrax scares in the US, I sat on some committees which looked at models of preparedness. I saw how technology can make a difference, and how a simple straightforward solution can make a big difference,” he said.

“In many respects, we were able to utilize insights we gained in developing solutions in the homeland security arena, where similar constraints of lack of internet connectivity, a need for rapid deployment, quick change cycle and robustness of a system for environmental factors are crucial.”

The next step, he says, is to continue the ability to collect and transfer information.
“We don’t need another algorithm analysis of data, we need to start dealing with the plumbing. We expect to improve data accuracy and expedite research so that scientists can focus on improving healthcare in developing countries.”