An infographic originally presented at the 2010 Future of Clinical Trials conference. Highlights key systems used in clinical research.

1. REGULATORY Title 21, CFR Part-11 defines the criteria under which electronic records and electronic
signatures are considered to be trustworthy, reliable and equivalent to paper records
1 SITE ID: 2 SITE ACTIVATION:
Bunch of web-based directories to chose from, This is the realm of darkness. 60% of users use Excel and the rest try to build their
mostly static directories stuck in the Web 1.0 single own custom solutions using Sharepoint and Projects. A few web-based solutions are
way consumption model. beginning to crop up.
Online directories, which are static and limited Websites which primarily serve
in scope. Clinicaltrials.gov is one of the 60% of professionals use Excel as a
workaround. as document repositories.
biggest. Plus it’s Free.
CD ROM
Mostly built by former clinical research
Internal Databases, which suffer from being managers. Very tab heavy and not user
quickly outdated and limited in scope and friendly.
reach.
3 STUDY CONDUCT:
CTMS: $2billion fragmented industry focusing After a decade of gradual acceptance, most sponsors use
on data, project, patient, investigator and
budget management. Pseudo SaaS. E some form of EDC. Still requiring duplicate and even triple
workflows! DC landscape has continued to evolve from its
evolution from RDE in the late 1990s, and today the market
D consists of a variety of new and established software
providers, such as BioClinica, Cmed Technology, DataTRAK,
e-Signatures
C Maestro CTMS (Libra Medical), Medidata Solutions,
Omnicomm Systems, Phase Forward, Phoenix Software
International, and Unithink serve the $1billion market.
IVRS/ePro: By most estimates, the ePRO market might be in the vicinity of $100 million in annual sales, making
it perhaps a tenth as large as the electronic data capture (EDC) market. The three apparent leaders—CRF,
invivodata, PHT—have enough international project experience to be able to handle large trials for big pharma.
But a host of firms also thrive in the sector and also have customers in big pharma. Those names include Almac,
Arrowhead, Assistek, Certas, DSG, ERT, Exco, Icon, Medrio, MetriSense, Perceptive and Symfo.
4 CLOSEOUT: Database is locked, a visit to the individual sites occurs where all study material is collected, queries (questions
about or inconsistencies in site reported information on CRFs) are cleared, all outstanding regulatory documents
are reviewed, completed and collected, and drug accountability is done. Study is then closed out at IRB and
Study Start Up Made Easy
payment reconciliations are finally done.
Emerging Standards? Platform independent data standard based on XML
to facilitate system interoperability (www.cdisc.org)
American based organization on mission to
standardize clinical data. (www.hl7.org)