Healthcare Services Group
including Clinical Trial Services
Exclusively through GCP-MB, LLC
Contents
Corporate Background
3
IDS Infotech’s Healthcare Services
5
Our Capabilities
17
Select Case Studies
20
IDS Infotech’s Best Practices
28
Page 2
Corporate Background
Twenty years of successful management in IT and Business Process Outsourcing
•
Established in 1989, IDS Infotech employs over 1200
people
•
Offices in 6 locations globally
• Located in Chandigarh, Mohali and New Delhi
(Noida), India, IDS is one of the largest Back
Office Processing Units in North India
•
Subsidiary - IDS America, Inc. founded in 2004
with offices in NY and Virginia
•
Support Office in the UK with additional Multilocation facilities in India as a part of Business
Continuity Plan (BCP)
•
IDS Infotech uses a seamless global delivery network
and extensive domain expertise to help any type of
business achieve rapid and sustainable cost savings,
improve cash flow and drive top-line growth
•
IDS applies the latest technological advances, a highly
educated workforce and total customer commitment to
provide cost-effective solutions to our clients around
the world
Page 3
Global Service Areas: Our experts successfully migrate processes—with quantifiable
results—in the following service areas
IDS Infotech
Healthcare
• Provides complete
healthcare business
solutions around the
globe
• Caters to provider,
payer, and
pharmaceutical
segments
• Services include
clinical data
management, medical
transcription,
accounts receivable
management,
electronic medical
records, insurance &
customer care
• HIPAA compliant and
ISO 9001:2000
certified
Engineering and
Design
Legal Services
• Caters to diverse
industry verticals such
as automotive,
aerospace, and
machinery
• Offers Clientdedicated teams, Six
Sigma processes and
leading edge worldclass technology
• Services include
Engineering Design,
Engineering Analysis,
CAD services, and
Manufacturing Support
• Specializes in ESI
processing, Document
review, legal
research, and paper
discovery
• Relationship
management by local
(EU & USA)
engineering personnel
• Caters to
corporations, law
firms, and e-discovery
Alliances
• Domain & sub-domain
expertise in all industry
verticals
• Value Analysis/Value
Engineering across the
product life cycle
• Expert team includes
certified ESI
processors, Attorney
reviewers, project
managers, and
litigation analysts
Content
Management and
Publishing
Solutions
Software Services
• Specializes in content
management and prepress services such as
data capturing, data
conversion,
typesetting, and
document scanning
• Caters to diverse
sectors, including
Retail, e-Commerce,
Network security,
Healthcare, Media
and Entertainment,
and ISVs
• Caters to the
production and
conversion needs of
publishers, knowledge
service providers,
professional
organizations and
universities
• Services include
application
development and
maintenance,
Technical helpdesk,
QA and testing
services
• Services range from
editing books to
academic and financial
publications involving
high volumes of
mathematical and
tabulated data
• Expertise in
technologies such as
.Net, Java, LAMP,
iPhone and in
designing and
developing Rich
Internet applications
Page 4
IDS Infotech’s Healthcare Services
Page 5
We offer end-to-end Healthcare services across the entire value chain, thus adding
higher value to our clients
Patient Record
Secure storage
and retrieval
Patient Records
Management
Appointment
Scheduling
Insurance
Authorisation
and Pre-cert
Medical
Transcription
IDS Healthcare
Solutions across
the Value Chain
Charge
Processing
Billing and
Claims
Patient Call
Answering
Clinical Research
Data Management
Receivable
follow-up and
Collections
Coding
Page 6
Our healthcare services
Healthcare Services
Provider Segment
Medical Transcription
Services (MTS)
Account Receivable
Management (ARM)
Payer Segment
Insurance Services Group
(ISG)
Pharmaceutical Services
Clinical Data
Management
Direct-To-Customer
Services
Medical Record
Digitization / Electronic
Medical Records (EMR)
Page 7
Payer
Segment
Provider Segment
Pharmaceutical
Segment
We cater to the provider, payer and pharmaceutical developer
segments
Clinical Data Management (CDM)
Clinical Data Management and SAS Programming services to Pharmaceutical Research Companies through GCP-MB,
LLC, providing both clinical and non-clinical services
Direct-To-Customer Services
Drug Information Services, Product Complaint Services, Drug Ad Response Hot line, Market Research, Patient
recruitment and screening for Clinical Research
Account Receivable Management (ARM)
Appointment Scheduling, Patient Registration in Practice Management System, Patient coverage and Benefits
verification, Coding, Charge Entry, Claim submission, Payment posting, Denial/Rejection Analysis, A/R Follow-up,
Provider credentialing, and pre-adjudication
Medical Transcription Services (MTS)
Medical Transcription Services to US Hospitals and MTSOs
Medical Record Digitization / Electronic Medical Records (EMR)
Online patient registration, medical template customization, data conversion dumping from old system to new system,
medical records day-forward conversion, and medical records backfile conversion for EMR system
Insurance Services Group (ISG)
Data Entry of insurance claims for insurance companies and TPAs
Page 8
Our experience in Clinical Data Management (CDM)
•
Clinical Trial Experience in Depression, Oncology, Psoriasis, Rosacea, Periodental disease, Lupus, HHID, Liver
failure, Asthma, COPD, Hypertension, Analgesics, etc.
•
Dedicated experienced project manager for each account with over seven years of experience
•
Team of twenty people who have expert knowledge in medical terminology and coding methods with average
experience of 3-4 years
•
Processing at an average 1000 records per day per person for clinical and non-clinical projects
•
Successfully delivered several complex projects well within expected budget and turn around time
•
Fully HIPAA Compliant process
Page 9
Our Process Flow Chart for Clinical Research Management
Version 1.1
PRODUCTION
IDS INFOTECH LTD
09/01/2009
YES
SPECIFICATIONS RCV’D FOR
NEW PROJECT
NO
CRFs
PROCESS>=20% OF
RECEIVED NEW
PATIENTS’ CRFs
PROJECT MANAGER READS
SPECIFICATIONS
ANY QUERY
YES
NO
PROJECT MANAGER
SENDS QUERY TO CLIENT
USING ISSUE TRACKER
NEW PATIENTS’ CRFs
ARE ASSIGNED TO
TEAM MEMBERS BY
TL/SPA
TL/SPA PREPARES
DAILY PRODUCTION
SHEET
CLIENT’S RESPONSE
RCV’D
QUERY ARISES
AT THE TIME OF
PROCESSING
PROJECT MANAGER
SENDS QUERIES THRU
MAIL TO THE CLIENT
QA PROCESS
STARTS
NO
ALL NEW CRFs
THRU QA
PROCESS
YES
QUERIES
RESOLVED BY
CLIENT
QA SAMPLING
PROCESS
STARTS
PROJECT
MANAGER
INFORMS TL/SPA
NO
QA SAMPLING
PROCESS IS DONE
NO
ANY
FURTHER
QUERY
YES
PROJECT MANAGER
SENDS
CONFIRMATION MAIL
TO CLIENT
TL/SPA ANNOUNCES
DECISION ON FLOOR
YES
PROJECT MANAGER
DETERMINES RESOURCE
REQUIREMENTS FOR THE
PROJECT
CLIENT IS INFORMED
BY EMAIL
TL/SPA GIVES TRAINING TO
TEAM MEMBERS
TL/SPA CHECKS FOR NEW
PATIENTS’ CRFs ON CLIENT'S
SERVER
TRAINEES FILL TRAINING
ACKNOWLEDGEMENT FORM
IDS INFOTECH LIMITED
Confidential
Clinical Data Management
Page 10
Our experience in Direct-To-Customer Services
For Patients
Drug
Information
Services
Product
Complaint
Services
Drug Ad
Response Hot
line
For Physicians
•
•
•
•
• Assist patients in better understanding the drug by answering their questions on
drug usage, side effects and any other issues
• Create database of prescribers, users, target patients
• Serve as help desk for consumers, information collection desk for marketing
division
• Serve as the first level resolution center, answering questions around: appropriate
therapy for specific patients; adverse reactions to drugs; efficacy of drugs; drug
interactions; intravenous additive incompatibilities; biopharmaceutic and
pharmacokinetic parameters of drugs; dosing in renal failure; appropriate therapy
for a disease state; identification of foreign drugs; and information on new drugs
Log in the received complaint
Filter the complaint into critical or non-critical categories
Address non-critical complaints and escalate critical complaints as per protocols set
Follow-up on the resolution with the complainant
This hotline can be used for any of the following purposes:
• Answer clinical or Benefit questions
• Collection of Patient interest data
• Clinical Counseling
• Product education – for the product on active promotion
Market Research
• Collect Socio Economic Statistics
• Conduct patient Satisfaction survey’s
• Conduct patient / physician Demographic survey
Patient
Recruitment and
Screening for
Clinical Research
• Screen the patients for recruiting in clinical trials based on the inclusion and exclusion criteria
Page 11
We managed over 50 clinical and non-clinical projects
Clinical Projects
Non-clinical Projects
Daiichi Sankyo
Vicept
BMS
Novartis
AZ-NXY
Genzyme
Astellas
GPC
Forest
AMI
Centocor
AtheroGenics
ARCA
Hemispherx
Allergan
Eisai
Astellas
Shire
Duramed
NeurogesX
AZ-Seroquel
Al Pharma
Pain Therapeutic
AZ Crestor
ALS (Advance Life Science)
Premier Research
Arca Biopharm
Galderma
Pain Therapeutics
Mits
Acceleron
Battelle
ALS (Advance Life Science)
Actelion
Premier
ARCA
Eisai
Ligand
Pharmacyclics
Hyperion
DSPA
PGx Health
Tracon
Nuvo
Premier Research
Prolexys
Synta
Auxilium
Novartis
EndoCeutics
Xanodyne
Poniard
Pharmasset
TMC Cangrelor
Pacira
Lux Biosciences
Page 12
Select Case Studies
Page 13
Case Study for Clinical Research Management
Client background
The client is one of the largest global Clinical Research Organizations having footprint in 18 countries. Services support the
entire drug development process cycle. Service offerings range from preclinical testing to clinical trials management (Phase I to
Phase IV) thus assisting pharmaceutical and biotech companies of all sizes to fulfill their research and development, clinical
trial, regulatory and marketing support needs.
Project background
Data entry of Case Report Forms (CRFs), as part of Clinical Trials Phase II and III, was expensive, time consuming, and created
a bottleneck in proceeding to the next stages of review for the client. CRFs were being entered by the client at the client’s own
production facilities. The client was looking for a way to eliminate the bottleneck resulting from the time consuming, low end 1st
and 2nd pass data entry of CRFs
Challenges faced by our Client
Our Solution
The client, being a global operator, has a centralized online database and the service
provider needed to have 24-hour access to this database
IDS Infotech established fire walled VPN connectivity between the customer’s Oracle
Clinical Database in the US and our operational facility in India
To eliminate the bottleneck, the client established a minimum turn around target of
21 days to process a backlog of 11,500 forms
All 11,500 forms processed by IDS Infotech in 7days. Post processing efforts by the
client was reduced significantly, as all manual discrepancies were resolved at 2nd
pass entry
Being a Phase III clinical study requisite, audit trails were required to ensure client
confidentiality
A secure, US based server was used to transfer scanned CRFs (images) to India. All
processes strictly followed the required SOPs dictated by the client
The client utilized Oracle Clinical, which required specific application knowledge and
operating skills
• IDS Infotech core team working on this project was trained by CRO in UK on Oracle
Clinical (OC)
• A T3 module created by the core team, with assistance from the client, allowed
efficient transfer of OC skills to India based data entry personnel
• Additional on-line training by teleconference and Web Cast was imparted to
facilitate knowledge transfer, resulting in OC expertise with minimal investment
Benefits to Client
• Accuracy: The accuracy of the delivered work was on average 98.5%
• Turn Around Time (TAT): The agreed upon TAT by the client to receive the indexed CRFs was 21 days whereas IDS Infotech delivered the same within 7 days
as we have dedicated team at IDS Infotech to do CRF indexing exclusively. Currently the team is working with a TAT of three days and meeting the same
consistently.
• Cost saved up to 40%: By using IDS Infotech personnel who are well trained to provide best of services there is no capital investment on infrastructure and
resources from the client’s side, the total reduction in the cost of the client is as high as 40 %. We were able to provide solution to the client to reduce the costs
involved in handling multiple databases as against a single database.
Page 14
Case Study: Our approach
Phase 1: Process
Assessment
•
Client visit: IDS Infotech team visited
the client’s site in the UK for three
months in order to understand their
process
• The client also visited IDS Infotech in
India and performed audit of the
facility for the capability testing to
perform clinical research related work
• We were compliant with all the
requirements
• Established Clinical Data
Management (CDM) processes at
IDS Infotech
• Trained the IDS Infotech team
Phase 2: Implementation
of Services
Gained access to client’s application
and database through secured user
IDs and passwords
• Provided the following services for the
CRFs Phase I, II and III of the clinical
trials
• Indexing
• First pass
• Second pass of the CRFs
• Quality Management of the studies
• Performed data indexing of all the
above mentioned studies, which is the
step two in data entry of Phase I
clinical trials
• The entire team at IDS Infotech
was trained online for data
indexing
• Conducted Quality Management: QM
is the final step in Clinical Database
check. The main objective of QM was
to ensure that the database is an
accurate reflection of the CRF and the
data review is appropriate and
consistent with study guidelines and
conventions
•
Phase 3: Quality
Analysis
• Post completion of data entry,
released the CRFs, which in turn were
saved in the client database for the
Quality Analysis at their end
Page 15
Case Study for Clinical Research Management
Client background
Our client is a leader in the electronic transformation of clinical R&D. They offer a suite of regulatory,
clinical, process and IT solutions. They have a proven record of delivering innovative solutions to leading
biotech and pharmaceutical companies.
Our Service Offerings
•
Received Case Report Forms (CRFs) and Data Clarification Forms (DCFs) for book marking and linking from the client
•
The overview of steps is as follows:
•
•
Case Report Forms (CRF) Book marking
•
Case Report Forms (CRF) Linking to DCF
•
Quality Check 100%
•
Second stage Random Sampling QA process
Assisted the client in both clinical and non-clinical projects
•
Managed over 50 clinical and non-clinical projects for the client
Project Achievements
Description
Volumes handled for Clinical projects
Volumes handled for Non-Clinical
projects
Total number of client projects:
68
30
Total number of files (PDF):
18306
1789
Total number of pages (CRF):
2132534
410954
Total number of DCF / Bookmarks:
173030 DCF
169748 bookmarks
Total number of Queries resolved / Links:
215917 queries resolved
124091 links
Page 16
Case Study for Clinical Research Management
Client background
Our client is dedicated to serving the Pharmaceutical, Biotechnology and CRO Industries by developing and
supporting state of the art software and services designed to facilitate a more efficient, effective and timely capture,
distribution and analysis of clinical data from paper or imaged CRF forms. It offers the possibility of electronic data
capture from paper or imaged CRF, including full verification, validation, data management and clean-up.
Our Service Offerings
•
Image Verification for CRFs
•
Verify the received images against online client data
•
Data Entry – 1st and 2nd Pass
•
Quality Check
•
•
Field Data Clarification Forms (FDCFs)
•
•
Check all records100% by comparing the data entered in the 1st and 2nd pass to ensure quality SLA
Data entry of DCFs including query resolution
Statistical Analysis Systems (SAS) in Clinical trials
•
Complete analysis of the patient data deploying SAS tools
Statistical Analysis Systems
The following steps are followed for performing Statistical Analysis in Clinical Trials
Import external
data
Data validation
Data analysis
Report generation
Page 17
Case Study for Insurance Services
Client: Third party Administrator
Client
The client is a leading Third Party Administrator and principally engaged in administering self funded healthcare plans for 300+
lives, single or multi-site employers and back shop claim processing. The client is responsible for the administration of an
employer’s medical benefit plan. They are also responsible for printing and providing ID cards and medical benefit plan
booklets, as well as processing and arranging for payment of medical claims.
Project Background
Challenges faced by Client
The client was looking for a partner who could help them to perform the
digitization of about 3000 medical claims per day. The client wanted to engage
cost effective service providers which can meet the expected TAT of 12 hour
for these claims with at least 99% accuracy. IDS conducted detailed study of
their requirements and undertook the pilot for the project.
The major challenges were to :
•
Cut on the paper printing cost.
•
Output in HIPAA 837 format. 3).
•
Achieve the turnaround time with the expected 99% accuracy levels.
Our Solution
•
The IDS in-house training team developed a fast track training program for the data entry personnel, and ramped up staff into its dedicated facility to the
required number on an accelerated pace.
•
Key processes were optimized to maximize productivity from the staff and all the team members were adequately trained and tested before putting them on the
project.
•
To meet the TAT requirements of our client, a special application was designed where we could open the client input files on the upper half of the screen and
index the data in our application in the lower half of the screen. Also this application recorded all the entries made and auto-populated the recurring data. This
saved a lot of time and increased the productivity of our team members. Also, we did not have to print all the input data received from the client.
•
100% quality sampling was done during the initial 2 weeks to understand the weak areas of the team and retraining sessions were conducted to improve on
them.
•
Daily feedback sessions with the client were conducted during the pilot phase to ensure customer satisfaction.
Benefits to Client
•
Client appreciated the performance during the pilot phase. They were particularly happy with the quick turnaround and the quality work.
•
Client gained the confidence on IDS, and they doubled up the volumes in 45 days.
•
Client started seeking solutions from IDS wherever they required our services that required any special treatments.
•
Cost Saving: The outsourcing concept resulted in huge cost savings to the client as otherwise they were getting the digitization done domestically which incurred
heavy costs compared to the off-shore digitization.
Page 18
IDS Infotech’s Best Practices
Page 19
We differentiate ourselves by following best practices in all our processes
Security and
Compliance
Project
Management
Global client
requirements
Our best
practices
Quality and
SLA
requirements
HR policies
Page 20
Our best practices
We follow a zero-tolerance security and compliance policy
Confidentiality &
Data Security
Personnel Level
Technology Level
Each employee is trained on the
Confidentiality and monitored for
any data exchange, either physical
or virtual
We have all the necessary security features to
ensure all data is not only protected, but stored
with a Business Continuity Plan.
We have a mirror site with NTT Vario with full
fledged secure servers and systems
Physical Security
All locations secured
by Security and
Electronic controls
HIPAA
Personnel Level
All IDS Infotech employees in
our Healthcare division undergo
a HIPAA Compliance training
Program and evaluated. Those
that pass only can work with
clients
Technology Level
We request for a HIPAA
compliance checklist from
the client.
Check list signed off once
technology requirements
are met
Contract Level
All locations secured by
Security and Electronic
controls
Compliance Officer
Dedicated Compliance
officer for HIPAA
Page 21
Our best practices
We understand Global Client requirements
•
No Downtime – Guaranteed 24x7 operations
•
100 percent link redundancy including Last mile local loop
•
5 Mbps Bandwidth with VPN - Easily scalable
•
Facility wide and inter facility level BCM
•
Data security audit process; ISO 270001 company; 100% data back up
•
Own US based secured, dedicated FTP, email and web server
•
Client confidentiality - NDA; firewalls at gateway/ remote server
Page 22
Our best practices
Our staff and HR policies have yielded lower than industry attrition rates
•
Strict adherence to Indian government rules for employee welfare
•
Staff covered under group medical insurance scheme
•
Ethical workplace practices
•
No employee below 18 years of age
•
Structured reward/recognition and performance appraisal system
•
Employee work place as per international standard
•
Induction and on-going functional training
•
Continuous feedback and improvement mechanism
Page 23
Our best practices
We guarantee Quality and Turn Around Time (TAT) SLA requirements
•
ISO 9001 certified QMS
•
Identify KRA in joint review with client
•
Process based, data intensive approach based on DMAIC
•
Well-documented SOP’s for maintaining project quality
•
Each SOP with clearly defined tasks and control points
•
Each task staffed with trained staff
•
Each task with well defined performance and quality metrics
•
100% QA to client. No dispatch to client without Quality Check
•
MIS to track and deliver TAT – within 24 hours or more
Page 24
Our best practices
We follow a least pain to the client, project management based migration approach
•
Establish Team Charter; understand business rules
•
Process a sample; analyze client requirements
•
Translate in terms of project resource requirements
•
Present solution costing to client; sign SLA
•
Setup process requirements
•
Phased approach: run a Pilot; tune process; incorporate improvements; continue phased ramp up till ownership of
full volume; MIS system for reporting & communication
Page 25
We have been certified for providing top-most quality while
maintaining security and confidentiality
ISO
9001:2008
QUALITY
The ISO 9001:2008
standard provides a
tried and tested
framework for taking
a systematic
approach to
managing an
organization's
processes so that
they consistently turn
out product that
satisfies customers'
expectations.
ISO
27001:2005
SECURITY
ISO/IEC 27001 formally
specifies a
management system
that is intended to bring
information security
under explicit
management control.
Being a formal
specification means
that it mandates we
meet specific
requirements.
HIPAA
COMPLIANT
CONFIDENTIALITY
HIPAA establishes
standardized
mechanisms for
electronic data
interchange ( EDI ),
security, and
confidentiality of all
healthcare-related data.
The Act mandates
security mechanisms to
ensure confidentiality
and data integrity for
any information that
identifies an individual.
AS
9100:2001
QUALITY
The standard adheres
to all the requirements
of ISO 9001:2000 plus
additional
requirements for the
aerospace industry.
Page 26
Safe Harbor Privacy Principles
IDS consider protecting the integrity and privacy of every confidential information as a
crucial part of our services. We have strict directives for Safe Harbor Privacy
principles and our security and policies are revised from time to time for better
scrutiny and privacy maintenance. With every such amendment, changes are made
in the processes and the technology so as to make both compliant.
Page 27
Our Clinical Trials support services are offered
exclusively through GCP-MB, LLC. For other services we
can be contacted at…
USA Office
IDS America Inc.
1501 Broadway, 12th Floor
New York-10036
India Office
IDS Infotech Ltd.
C-138, Phase VIII,
Industrial Area, Mohali, India.
Europe Office
IDS Infotech Ltd.
Croy 7 5653 LC Eindhoven
The Netherlands
Tel : (+1) 734 276 5260
Fax : (+1) 703 462 5459
Tel : +91 (172) 509 1601/602
Fax : +91 (172) 509 8475
Tel : +31 (0) 40 256 16 02
Fax : +31 (0) 40 256 11 05
www.idsil.com
This document details information and methodology of a confidential nature given by IDS Infotech. No part of this document can be used, reproduced
or disclosed to any third party without the written prior consent of IDS Infotech.
Page 28