Observations, Issues, Benefits: Mobility in Life Sciences [2012]

1. Drivers for Mobility
Observed industry trends that are causing an explosion of growth
Improved,
increased
mobility
Intense
Competition
Cost Reduction
Evolution and
fast adoption of
mobile
technology
Emergence of
cost effective
mobile platforms
Improvements in
mobile security
Maturation of the
use of mobile
applications from
simple uses to
complex tasks

2. Those who are now adopting mobility
Functions that have an immediate positive impact with the march towards mobility
Research
•Lab automation
•Laboratory equipment management
•Lab and clean room maintenance
•Lab data collection
Clinical
•IVRS
•PI and Study Coordinator interactions
•CTMS
•Study Supplies
•PRO
Regulatory and Validation
•Audit
•Security
•e-Signature
Manufacturing
•Asset auditing
•Calibration
•Equipment maintenance
•Facilities management
•Inspections
Commercial Operations
•Samples Management Compliance
•CRM
•Field service
•IT asset management

3. General areas where mobility can address
Considerations for a mobile-driven enterprise. Provide seeded and focused engagements in these
Discovery
•Labs are distributed across multiple regional
locations, data collection is a challenge
•Electronic forms and instrument interface to be
updated on real time basis
•Integrity and security
•Asset management
Development
•Timely data collection and real-time update
•Stringent Regulations
•Patient management
•Managing irregularity
Commercial Operations
•Physicians overloaded with information;
•Promote and leverage adoption of hand
devices
•Drug and treatment effectiveness are
compromised
•Revenues fail to reach anticipated levels
Mobility Addresses
•Syncing with central repository
•Automatic & quick integration
•Wireless track and trace assets
•Communicate with CRF’s
•Monitor & Investigate to-do lists
•Creating Reference
•E-detailing for sales reps
•Track and show prescription
histories
Applications Available
• Protocols, SOPs on phone
• Lab management support
• Clinical (Imaging, patient
management, eCRF,
investigator)
• AERS reporting
• Batch bar-coding
• CRM
• Revenue management

4. Issues Mobile Improvements Business Benefits
Research laboratories and facilities are
geographically distributed, making data
collection and integration burdensome
Mobile applications allow independent
researchers and facilities to
communicate, and enable synching and
transmission of data to a central
repository in a timely manner
Reduced reliance on paperwork and
manual data entry
Increased efficiency
Lower operating costs
Less opportunity for human error,
inaccuracy, missing data
Voluminous data resides in conflicting
formats -- researchers' handwritten
notes and outputs from laboratory
instruments -- and must be integrated
and put into electronic format, often
manually
Mobile devices such as IBM's
TransNote ThinkPad laptop allow
researchers to record and submit notes
in a common, electronic format,
enabling automatic and quick
integration
Timely and automatic data collection
Earlier availability of data
Faster path to NDA submission and
clinical trials
The integrity and security of physical
environments must be ensured
Using chips, locator devices and
wireless networks, laboratories can
track and monitor sensitive equipment
and assets
Avoid compromised data, breaches in
research environment
Increase reliability of data
Avoid costly re-works and delays
Mobile laboratory "assets" --
equipment, animals, chemicals, etc. --
require tracking and monitoring
Mobile applications can monitor
laboratory assets, and also assist in
tracking and finding assets that are
moved among physical locations
Locate assets
Protect investments
Reduce theft, loss and damage
Comply with regulations
… Where mobility improves Research
_

5. Issues Mobile Improvements Business Benefits
Mobility of parties makes it difficult to
communicate, share current information
in a timely manner, collect data and
schedule meetings and training
Mobile applications allow parties to
communicate at will, synch and transmit
data and documentation (CRFs, drug
logs, etc.), share notes and calendars,
and schedule appointments
Improved communications
Earlier and more timely sharing of
information
More effective trial site administration,
accounting, site closure and audits
Better cost control
Trial monitors and investigators must
understand and observe a plethora of
strict rules for trial management and
compliance with regulations
Mobile applications can provide
monitors and investigators with to-do
lists and other guides to trial rules and
management, and automate the
production of audit trails through data
and time stamping to comply with
regulations
Better trial management
Improved compliance
Better cost control
Investigators must perform a variety of
tracking tasks and fill out paperwork for
patient screening and enrollment, drug
usage, budgets, supplies, CRFs,
adverse events, biological samples, etc.
Mobile applications can assist
investigators in performing all tracking
tasks by creating forms for patient
screening and enrollment, drug
regimens and ordering supplies, etc.;
and by printing labels and handling
information for biological samples
Fewer exclusions and invalidations
Fewer protocol violations
Increased compliance
Better cost control
Timely collection, analysis and
validation of patient clinical data is
difficult due to unautomated data
capture methods. Accuracy and
reliability of data is suspect,
inconsistencies are prevalent, and data
collection and transmission occurs
irregularly
Mobile applications prompt patients to
record required clinical data and
information in prescribed, common,
electronic formats. Enables quick,
timely and easy transmission of data to
central repository for analysis, reaction
and trial adjustment. Fulfills regulatory
compliance.
More efficient data collection
Improved data accuracy and quality
Accelerated time to market
… Where mobility improves Development (1)
_

6. Issues Mobile Improvements Business Benefits
Essential to train investigators in
conducting and administering trials,
completing CRFs, and avoiding
protocol violations, but scheduling time
is difficult, and lengthy documents
preclude easy reading, retention and
reference
Store a variety of trial documents
(protocols and potential violations,
clinical practice tutorials, rules for
sample handling, inclusion/exclusion
criteria, annotated CRF templates) on
investigators' mobile devices for easy
reference
Better trial management
More accurate administrative records
Improved regulatory compliance
Fewer protocol violations
Better cost control
Quicker report generation
Accelerated time to market
… Where mobility improves Development (2)
_

7. Issues Mobile Improvements Business Benefits
Major markets saturated with sales
reps; physicians overloaded with
information; duration of effective
details shrinking
Use mobile applications to perform e-
detailing. Reach physicians through
emails, online advertisements and
other electronic information sent
directly to handheld devices
Ability to share rich information
Greater number of effective details
More cost-effective details
Gain greater mind share and market
share
Reach physicians in remote areas
Ability to convey complex, accurate
and complete drug information in short
windows of time
Arm sales reps with mobile devices
containing complete, up-to-date
marketing information; synch
information on periodic basis
Ability to convey rich information
More productive detail visits
Limit need for follow-on detail visits
Promote and leverage adoption of
handheld devices in physician
community
Sponsor (to some extent) the supply
of mobile applications and devices to
physicians in exchange for increased
access, content posting, etc.
Develop more cost-effective marketing
and communication channels
Completing administrative tasks in a
timely manner from the field
Outfit sales reps with mobile
applications to perform administrative
chores such as expense reporting,
drug sample logs, etc.
Reduce administrative overhead
Better cost control
… Where mobility improves Commercialization
_

8. Issues Mobile Improvements Business Benefits
Drug and treatment effectiveness are
compromised when patients fail to
comply with drug regimens
Physician mobile applications can track
and show prescription histories,
including whether a patient filled a new
prescription and/or obtained a refill on
time.
Raise compliance rates
Increase drug utilization
Promote drug effectiveness
Maximize revenues
Revenues fail to reach anticipated
levels when patients under-utilize
prescribed drugs
Mobile applications like those cited
above, plus other innovations -- smart
chips embedded in prescription
containers; email alerts for drug
expirations, renewals; wireless
messages prompting patients to take
drugs
Raise compliance rates
Increase drug utilization
Promote drug effectiveness
Maximize revenues
…Where mobility improves Patient Compliance
_