1. Abstract
Since inception Clinical world has become an ocean of data
originating from all possible sources. With increased complications in medical
industry the demand of precise medicines and devices are increasing. The
clinical databases has become advanced and comes with feasibility of collecting
and mapping of data from any sources. However, the increase source data has lead to complex integrations and requires ample storage space.
The biggest issue in current industry is to how bring all
data together to run analytics and business intelligence. The concept of having
a hub is as important as having a clinical database for a study. Integrating
the hub by having all clinical data at one place makes analytics to run
seamlessly and precisely.
2. Introduction
Integrated clinical hub is a concept of having
a central repository of data from various clinical and non-clinical sources.
The data to be either integrated online or imported offline based on the study
configuration and frequency. The hub helps in identifying any datapoint or
event or patient history at one go without referring to multiple databases.
Clinical analytics would be an ease using
integrated clinical hub and results would be acceptable being run on a vast
data. The hub used could be a clinical database or some platform similar to it.
3. History
Since
inception of CDM business by in-house teams and outsourcing from various
vendors, the amount of data and it’s sources are getting increased. For any
given study information on patient/ subject is generated at site level as well
as through IoTs. Information from eCRF and non-eCRF sources are very important to
be captured, stored and analysed at one place. Analytics driven trials were
only based on clinical data coming from study sites, however now a days
increased outsourcing has given importance to the CROs and IT/ BPO
organisations. Hence, the need of time is a single efficient repository for all
clinical trial data for analysis and further review.
4. Intended Users
There are multiple industry challenges at both
sponsor and IT solutions end, they are:
·
Sponsor/ CRO
o Difficult to integrate
multiple sources of data
o Multiple source data formats
o Data Integrity Issue
(Restrictions required for different groups)
o High-cost solution
o Ample IT dependency
·
IT
o Complex setup of external
data source integration
o Availability and setup of
on-line tool
o Ample rework for every new
study
o High maintenance of existing
systems
o Complex solutions/ systems
for simple tasks
6. High level Data Flow
7. Conclusion
The
integrated clinical hub is regulated by a centralised repository intended for archival,
processing, categorising, analysing and reporting of clinical data, hence this
serves as a one stop solution for analytics and reporting. The use of
integrated clinical hub would save time and provide clear idea of study data
and reporting.
With
the help of online and offline feature to integrate source data, the hub
becomes a handy platform to use with a minimal costing. Moreover, the plugins
for external analytical systems, e.g., SAS, tableau, MS power BI, spotfire is
an add-on. As the integrated clinical hub is able to produce extracts in
different formats, hence using them for different intents by different tools is
not a problem.
8. Abbreviation
|
SAS
|
Statistical Analytical System
|
|
IT
|
Information Technology
|
|
CRO
|
Clinical Research Organization
|
|
CRF
|
Case Report Form
|
|
eCRF
|
Electronic Case Report Form
|
|
IoTs
|
Internet of Things
|
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