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 * +1-484-537-5700

 * Our Solutions
   
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RESOURCE LIBRARY

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* Case Study
* Fact Sheet
* Webinar



ANONYMIZING RARE DISEASE DATA


AVOIDING DELAYS WHEN SEEKING COMPLIANCE FOR RARE DISEASE POPULATIONS

The challenges facing the Sponsor required the  Real Life Sciences and the
Sponsor teams work through complex issues together.  Working with rare disease
populations requires compliance strategies be thought through carefully in
advance. Small populations, like those found in rare and ultra-rare disease
populations can increase the likelihood of patient re-identification if advanced
methods are not applied.

Regulators may initially be hesitant to approve anonymization that strips out or
redacts large portions of pertinent information.  Working together, the Sponsor
and Real Life Sciences performed anonymization and quantifiable risk modelling
ahead of the first meeting with regulators. This provided near immediate
alignment with regulator expectations and avoided downstream rework and time
consuming iterations (a frequently reported issue across the industry). 


TRANSPARENCY AND DATA ANONYMIZATION FOR RARE DISEASE POPULATIONS

This Sponsor cares deeply about data transparency in its commitment to advance
life-changing treatments. Rare Disease populations that the Sponsor targets have
a variety of data anonymization challenges.  Small trial populations limit the
scope of what can be disclosed and incomplete anonymization carries with it a
large risk to re-identify individuals.  

Conversely, regulatory bodies and pharmaceutical organizations  are seeing an
increase in data sharing -- and Rare Disease populations are not exempt. New
regulations such as EU 536 will continue to make it even more critical  for
sponsors to maintain a reliable method of data transformation, and a business
process that is repeatable, efficient and applicable across trials and adheres
to the requirements of multiple governing bodies.


AN EFFICIENT CROSS FUNCTIONAL PROCESS TO SIMPLIFY SUBMISSION COMPLEXITY WHEN
WORKING WITH RARE DISEASE POPULATION DATA.

To achieve sustained success, cross functional teams need to be aligned when
solving transparency and anonymization challenges.  This is particularly true in
environments with advanced data anonymization complexity, such as rare disease
trial populations. Bringing together Medical Writing, Compliance, Data Security,
Biostatistics, Regulatory and Transparency teams to a single process will reduce
the risk of missteps that small patient population clinical trial data sets can
bring during the process of anonymization.  

Real Life Sciences generated a whitepaper for the Sponsor that defined best
practices including roles and responsibilities needed in transforming small
population data on a trial by trial basis. The Sponsor was able to leverage
these best practices to streamline processes and align internal teams. 

Much of the success surrounding data anonymization for the unique populations at
the Sponsor organization stemmed from the ability to create a detailed process
to review with regulators at the outset. Cross functional clarity and detail
accelerated the regulatory process and minimized the need for rework in
populations where the margin for error is exceedingly small.


RESULTS

 * Successfully performed risk assessment achieving Health Canada’s .09 risk
   threshold.
 * Authored whitepaper describing regulatory requirements. roles and
   responsibilities, tools, methodologies and process maps. Used for
   cross-functional training and process alignment with Medical Writing,
   BioStats, Regulatory & Clinical Ops.
 * To ensure alignment, proactively completed anonymization and risk modelling
   methodology and approach prior to initial (PIM) meeting with Health Canada
   regulatory authority.


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565 E. Swedesford Road
Suite 205
Wayne, PA 19087
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1.484.537.5700



PROTECT

 * Features
 * What is MD-DUO
 * Anonymization Services
 * Transparency & Regulations
 * FAQs


REVEAL

 * Features
 * What is SPEC-F
 * Published Work
 * FAQs


ANONYMIZATION SERVICES

 * Services
 * FAQs

 * Insights
 * About
 * Careers
 * Contact

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