Back to the Top
I have few doubts and clarifications on BA/BE studies:
1. BA/BE studies are very short term (only few days)..is it worth to
do data management with oracle clinical/clintrial?-this is consuming
lot of time as we have to design the CRFs, design the database etc for
months together for the studies which take up just few weeks!
2. What is the industry standards on BA/BE datamanagment systems?
3. Is RDC/EDC systems better for BA/BE data management?
4. Is it a must to medically code Concomitant medications and Adverse
events using medical dictionaries in BA/BE studies?
5. How good is openclinica for RDC/EDC for a small studies. Is it
really cheap (if buying an enterprise edition) when compared to other
costlier Datamanagment systems?
Thanks in advance for your valued inputs.
Back to the Top
I had been busy with training and other official work, hence the
delay. I will try to answer your questions and make a few suggestions.
It's going to be a long answer, and I hope there is no cut-off imposed
by the moderator of the forum.
Answer to Q 1: Depends on individual company strategy. Good part: data
is organized. Bad part: Too much time and manpower required, can upset
budget to great extent considering license, server, manpower, BCP,
data archival costs. In my past experience in BA/BE, the company I had
worked for, tried to do the same and ran into lot of challenges as new
strategies had to be implemented. Hence not all paper studies were
converted into electronic form, Moreover, in my current role in CDM
biz dev support, I came across applications like ClinTrial and OC,
which are actually not designed to handle BA/BE (Some friends in
Oracle openly admit this fact). Hence managing studies on such
software is generally not recommended.
Answer to Q 2: In case you are referring to some software or "good BA/
BE study data management practices", frankly I have come across none...
Answer to Q 3:Let me begin my answer with the following facts and
statements: (a) BA/BE studies are conducted usually on single sheets
of paper based on event like dosing, blood collection time-point, etc
and each sheet has multiple subjects on the same sheet.. right? This
is done to save time.
(b) OC/ClinTrial do not support "single sheet format". Instead CRF
will have to be prepared for each subject.
(c) Imagine recording events on paper CRF booklet instead!! We did
this once for 18 subjects and man! it was a mess. We had 2 mins
between each subject's blood collection, in these 2 mins, blood had to
be collected, and phlebotomist had to enter details in (lets say page
10) of each of CRF's. The coordinator went mad flipping pages of each
CRF and handing it over to phlebotomist, thus trying to save time and
avoiding a sample timepoint deviation. (This was done since the idea
was to compile information directly into 18 CRF's instead of loose
sheets of paper - and we had a lot of confusion. Now imaging entering
into RDC. In 2 mins, phlebotomist has to open say - page 10 on each
electronic CRF of subject, and enter information after collecting
blood. Can we do it in 2 mins??? The system may take some time, and
God forbid if LAN or internet connection becomes to slow/breaks up
completely. Another option is to keep data entry specialist who will
enter data as per phlebotomist's instructions, but then how will the
duty delegation be documented? Is it worth to hire data entry people
and spend so much? Hence RDC will not be a good option.
(d) The company, where I worked, also tried to adopt the following
model : prepare single sheets as in (a); then design paper CRF and get
it approved from OC team. The info from loose sheets will go into
respective columns/pages of CRFs of each subject. Obviously, this
activity would be performed after end of study and after QC of source
documents. The information on paper CRFs will then be entered by data
entry personnel into OC. In this scenario, just imaging how much time,
manpower is required. Also more chances are there for transcription
errors!!! In such scenario, there is no need of RDC systems and
licenses and therefore more costs. OC-Data Management component/
ClinTrial can do. As you can see, in this case, the cost involved and
turover time was high, and not all studies could be entered into CDM
software due to a lot of restrictions...
Answer to Q 4: Its not a must but its advisable to code events
Answer to Q 5: OpenClinica (free version) allows you to design CRFs,
perform data entry, etc. but its not validated. Regulatory authorities
will never rely on non-validated software. Also, in case you follow
the path described in answer to Q 3 part (d), which seems most
logical, it means that paper copies will be source documents and will
have to be preserved. These will be documents that should be used for
submission. Having software like OpenClinica, etc will be an "add-on"
to keep records electronically...Regarding OpenClinica enterprise, you
can take a quote from Akaza research. In my opinion, even smallest
pharma setup should need 5 licenses, so you can go ahead take the
quote (I guess it will be cheaper than other commercially available
Instead of your company purchasing software & having a whole data
management team, you can outsource this offline CDM activity to
vendors that have their own licenses of Oracle Clinical, etc and have
data management teams as well as tech support staff too. This model
will be very cost effective.
Also, PhaseForward's products and Medidata Rave are some software that
are available on "per study basis" from the vendors themselves. They
will install and host the software/service at their end, all you need
to do is to have access on "per study basis". This model is different
from the one suggested above because now you will have to keep data
management persons only instead of completely outsourcing the CDM part
of study. Negative point: If you do not have many studies, then your
company will have to bear cost of data management persons who would be
sitting idle during the time there is no work to do.
To sum it up:
1. I have not seen many BA/BE activities happening on CDM software due
to costs and complicated procedures that need to be followed. 2. Your
company can do it but "real time entry" may not be feasible since it
may cause time-point deviations 3. You may try to keep costs low
through points mentioned in "Suggestions".
I will be available for any further questions.
Dr. Gagandeep SinghSr. Consultant, Cognizant Tech Soln.
Want to post a follow-up message on this topic?
If this link does not work with your browser send a follow-up message to PharmPK@boomer.org with "BA-BE data management" as the subject
Support PharmPK by using the
Copyright 1995-2011 David W. A. Bourne (firstname.lastname@example.org)