Winter 2007
Capturing the Impossible: an eDC Adventure into Africa

Thursday 6th December, New Jersey, US. As I sit at my desk in my heated apartment, I gaze out the window past the Christmas lights and onto the snow-covered roofs. It's a far cry from the views I had less than two weeks ago when myself and my colleague were on the equator completing the last leg of an amazing trip... a trip that involved fifteen flights and around fifty hours of flying, visiting six countries, coordinating a project team over three continents and four time zones on a daily basis, and all in just four weeks; a trip to demonstrate the feasibility of (RR) eDC – (Really Remote) electronic data capture in Africa using TimaeusCmed's answer to capturing clinical data in Africa...

I had set the 'go no-go' decision date to Friday 12th October and this was cutting it close. After all, there were numerous activities requiring immediate attention if we were to stick with the proposed plan of departing the US on Wednesday 31st October to liaise with the UK project team the next day in London. The green light for the project came two days early as the folks upstairs in Cmed and our pharmaceutical partner agreed that the demonstration of a successfully simulated eDC study, run across three African countries with ten geographically unique centers over a four week period, would be very much in both of our interests. The key word here being 'success'. Two things would contribute to that success – or lack thereof; a carefully executed plan and an electronic data capture system like no other. The latter was being configured in London as I ran about the East coast of America worrying about the former.

As I mentioned earlier, I was to travel with my colleague Jerry, training manager for Cmed in North America. I had worked and traveled with Jerry plenty and knew that we would work well together. After all, for a trip as intense as this, it's simply a matter of 'get on, or get away'. We're still talking...

The plan was in place and we both had checklists in every pocket. Most important were the immunization shots and the visas. Knowing the importance of the shots, we had gambled on the project going ahead and had been turned into human pin-cushions a few weeks earlier. I only needed Yellow Fever since I was up to date on the rest; Jerry was not so lucky; Hep A, B, Polio, Typhoid, Yellow Fever, MMR, Tetanus... the list went on and on. He was a walking lab! For the visas, Jerry had spoken to all of the consulates for the countries that we planned on visiting (Burkina Faso, Tanzania and Kenya) and discovered that we could actually acquire all of our business visas in a single day in New York. The specialist visa companies were quoting three weeks minimum and triple the cost!

No stones were left unturned as we packed for the unknown. Hand-sanitizers, sun block, compass, iPods, GPS, shades, hats, ear-plugs, more medicines than a well-stocked pharmacy, and we had yet to pick up the 'field kit' in the UK. Getting all of this gear on board would surely involve an Herculean wave of creativity. It did!

The last two weeks before the departure from the US were spent confirming flight schedules, hotels, local transport, meetings with site staff and finalising all project and pilot study documentation. Neither I nor Jerry had been to sub-Saharan Africa before and we were pretty excited on the way to Newark airport. We had no idea of what lay ahead. Now that's what I call a good day at the office!
"Within minutes my hotel room looked like the central operations room for an intelligence agency. Jerry was on the balcony positioning the mini satellite dish in an easterly direction with one hand while fighting away giant flying creatures with the other"
On arrival in Gatwick, we made our way to Cmed's offices in Horsham and following a quick shower and change of clothes began preparing for the meeting with our partner company. We had set up a dedicated operations room for the project where it would be possible to have a live real-time view on big screens of the data that would hopefully be streaming in from the proposed sites over the next four weeks. In addition we had set up remote access for our partner so that they could participate in the action from their own offices. This was a simulated eDC trial in every sense and all roles were being exercised; Data Managers, Lab Loads, Trial Administration, Coding, Database Configuration, Database Exporting, etc. We also liaised with the technology team and checked all of the equipment that made up the 'field kit'. There was lots of it and our packing skills were pushed to their limit. Essentially we would be taking four small laptops, a mini satellite dish, lots of cell phones, our new eDC tablet and an assortment of cables and chargers that would make even the geekiest heads spin with excitement and envy. On top of this, we had personal laptops and enough camera and video gear to rival Nikon Africa™.

We arrived at our first destination, the capital city of Burkina Faso, Ouagadougou, at nine in the evening on Saturday 3rd November after about six hours of flying and a brief stopover at Charles De Gaulle. We were still on GMT! The first striking thing was that apart from the native languages, Moré and Dioula, French was the language of choice here, and English was spoken by very few indeed. I had enough French to get by and was very glad of it. The second striking thing was the heat, and by the time we cleared immigration and health checks and retrieved our luggage, we were drenched. On exiting the airport we were greeted by an unusual sight (and sound) of a local brass band marching past and playing 'Glory glory Alleluia'. Then came the line of street hawkers. Eventually we made it to the comfort of our hotel in a people carrier that was held together by seemingly nothing other than a fear of falling apart. We were excited, tired, but full of anticipation. We had a job to do and we would waste no time. The very first thing to be unpacked in our rooms was the Timaeus, our eDC system. ET needed to phone home!

Within minutes my hotel room looked like the central operations room for an intelligence agency. Jerry was on the balcony positioning the mini satellite dish in an easterly direction with one hand while fighting away giant flying creatures with the other. I remained in the air-conditioned room monitoring the four eDC stations that were now all 'live' and communicating with each other via their own WiFi network and with the rest of the study stations (in the UK) via the sat-link from our balcony. I keyed in some patient data from our pre-prepared data scripts and minutes later this information was available to all who had access around the world. We could sleep tonight. Tomorrow we would be traveling to our first site where we would demonstrate the system to them and hopefully enter and transmit simulated patient data from the site. We would also be testing the other communication modalities available to us, including local area network and GSM (built into each eDC station).

We stuck to coffee, toast and cereal for breakfast, leaving the more adventurous options to other guests, and at eight thirty were picked up by Yabo, as arranged. Yabo was a local who knew everyone and everywhere and was just the kind of person we needed to know in such a foreign world.

He took us to the CNRFP, the national center for malaria research, where we were met by a team of very friendly research doctors and study coordinators. Following introductions and a quick presentation, we dialed in to our first daily teleconference where we were happy to report on our progress thus far. We held the proceedings in French for the benefit of our hosts. That day we also demonstrated successful connectivity using the LAN at site, despite the bandwidth being too slow at times to view web pages.

We had not yet managed to communicate using GSM (i.e. the mobile phone network) despite the ubiquitous cell signal. Our technology team needed to make a few configuration changes to the system so that we could use a local ISP, rather than trying to dial internationally to the UK or US. We found out very quickly that international data calls were neither cheap nor reliable. By the end of the week we were communicating solely over GSM and had demonstrated a working electronic data capture system in two very remote vaccination centers with generators as the only source of electricity and no cabled internet access within fifty kilometers. Yet, the cellular network signal was everywhere, and so were their billboards; "Celtel – Partager. Notre Monde". Our job was getting easier. Everywhere we left site staff longing for a data capture system like ours. Our initial anxiety was slowly turning into excitement as we realised the true potential of our system in Africa. Next stop, Tanzania... or so we thought!

By the end of the week we were communicating solely over GSM and had demonstrated a working electronic data capture system in two very remote vaccination centers with generators as the only source of electricity and no cabled internet access within fifty kilometers.

The Air Burkina flight was delayed at Ouagadougou airport. It had cost us five thousand West African Francs to 'convince' the airport staff not to have our bags of equipment checked in the luggage hold. Apparently there was a mismatch between the number of people on board and the number of tickets issued. The lady sitting next to me was from Mali and she told me in excellent English with a French accent.

"...this is part of traveling in Africa you know. They regularly invent excuses like this when they have to fix some part of the plane or wait for the crew to arrive..."

Great, we were surely about to miss our connection on Air Kenya to Nairobi, and then on to Dar es Salaam. We sat there for three hours, despite being the only scheduled departure (or arrival) during that time. As Leonardo DiCaprio says in his recent movie 'Blood Diamond'

"TIA – This is Africa"
Of course we missed our connections. The only problem was that we had neither local currency nor visa for Mali and now had a requirement for both, as it seemed that we would need to stay in Bamako until we could arrange an onward flight. It was late on Saturday evening, all computer systems had shut down for the evening, and being Sunday the next day, would not be running until six in the evening – an hour after the scheduled departure of the next flight to Nairobi! After about an hour of running around outside the airport without a visa, we eventually converted some dollars, purchased a visa, met with some airline representative and flagged a taxi to a hotel – which only made it half of the way before ditching us in a dark alleyway. I was beginning to think all adventure was born in Mali.
Eventually we made it to our hotel, and even managed to secure onward flights to Nairobi the next day. And in a lesson of how to turn a disadvantage into an advantage, while in the departure lounge of Mali airport the next evening I logged into the eDC system as 'trial administrator' and amended the database to include a new country and center. I transmitted ten subjects' data before I had to close the laptop and board the plane. We didn't just boast unscheduled visit and unscheduled page functionality, we had just added unscheduled stops too! Roll on Tanzania.
Following a long uncomfortable flight in row fifteen (the non-reclining seat!) and a rescheduled connection in Nairobi to Dar es Salaam via Zanzibar, we finally arrived in Tanzania. I hated the place and everybody there. Deep down I knew that this would happen; traveling rule number one, the attractiveness of somewhere new is directly proportional to your state of mind, the content of your belly and the amount of sleep you've just had. We were low on all three and it would take days to see that Tanzania and its people were truly amazing, just as it was in Burkina Faso. This was true of all Africans that we met – east and west, and has greatly altered my perception of this amazing continent.
"Traveling rule number one, the attractiveness of somewhere new is directly proportional to your state of mind, the content of your belly and the amount of sleep you've just had"
A couple of hours north of Dar es Salaam by taxi and we arrived in the historical Swahili town of Bagamoyo, once a terminus of the slave caravan route.

Within a couple of days we had once again demonstrated to ourselves and the dedicated site staff that our data management system was fit for the job. In fact, I was beginning to realise that Timaeus was a true 'All Wheel Drive' machine. It's as if I had only been driving around on American highways for years and, now that I'd taken the system off-road, I'd discovered another gear stick, independent suspension and heated seats.

On the Thursday of week two, we returned to Dar es Salaam for a connecting flight to Arusha, a town at the base of Mount Kilimanjaro at an altitude of 1380m above sea level, home of tanzanite, and starting point for most safaris in Tanzania. Like everywhere else that we'd been in Africa, there was excellent cellular signal everywhere that we went, even in the center of the famous Ngorongoro crater, allowing us to transmit and receive data in near real-time.

Eventually we made our way back to Nairobi in Kenya and up to Eldoret, Nambale and Busia on the Ugandan border, meeting with friendly site staff, demonstrating our eDC system, setting up new centres and all the time entering data, responding to queries that were being generated by staff in the UK and testing the system in a variety of situations and environments. Each day we would report our progress in a teleconference with project staff around the globe.

By the time we were ready to leave Africa at the end of November we had successfully used Timaeus in four African countries to enter and transmit over four hundred patients' worth of data from nineteen geographically unique locations. While it may sound unbelievable, some of the data was actually entered and transmitted within twenty feet of wild elephants and giraffe deep within the Masai Mara plains of Southern Kenya.
Well now we're back in the US, the kit is back in London, and the post project meetings have begun. Personally, it has been an amazing experience and a privilege to have worked on this project and to have experienced Africa and Africans as I have. Regarding Timaeus, I have no doubt that it will be returning to Africa in the near future and will be a key player in clinical trials of the future.
Daragh Ryan has been a Project Manager for Cmed since 2002 and has worked on a wide range of pharmaceutical projects in software development, business development, in clinical operations and in data management.