Your Pharmacovigilance Health

Sciences Services Partner

Overview

About Think I

Pharmacovigilance Services

Leadership Team

Our Values
 ADR reporting
Safety contact
centre Medical
Your Information
Pharmacovigilance
Health Sciences Data Entry
Services T
Partner Case Signal
H
Processing Detection
Take a look at our I
process flow N E2B
K Submission
Literature
search MeSH search
YOUR I
COMPANY Aggregate DSUR, SUSAR,
S reporting ASR
e PADER,
r PSUR/PBRER ,
v Addendum
i Medical
c White papers
writing
e
Pharmacovigil End to End PV
s
ance training training
Safety Argus & AB
Database Cube
 Corporate Facts (Contd..)
Lineage:

Think I is a part of the Tenet Health Edutech

family, a 11 year old quality health sciences
training and consulting firm which boasts of state
of the art training and extensive consulting
experience with the life sciences companies.

Think I represents expertise, high quality, and

cost-effectiveness to the users. The same vision
has been translated into Think I as it has entered
in health sciences services arena in 2013.
 The Think I Advantage
Client-centric Engagement Model

Our deep-set commitment to our clients defines how we do business, and

the vast array of services we offer. We build our teams around your domain
and technology requirements, offering specialized services and solutions
that meet the distinct needs of your business.
We believe in providing the right amount and quality of work at the right
cost at the right time.

Experienced Team

An eminent panel which possesses superior medical knowledge and English

writing skills to cater to global organizations as well as Indian organizations.
The staff are pre trained at our sister organization, Think I, an internationally
accredited Pharmacovigilance training organization. Entire team is GCP and
GPV trained and certified.
Team experienced on Oracle Argus Safety, ARISg and other proprietary
safety databases.
 The Think I advantage (contd..)
Quality as a way of life

Think I systems, infrastructure, processes, IT are successfully audited by

global auditors

Data security

Strong IT Systems, Servers & Processes

Well secured offices physical and electronic security monitored 24x7
24x7 power supply and power back ups
Internationally accepted, state of the art data handling systems
Confidentiality agreements signed by all staff and vendors

Ethics and Compliance

Use of tried and tested business practices

Aim to cultivate and nurture long term relationships with all our
stakeholders
 Infrastructure
Delhi National Capital Region (NCR) is considered the
hub for education and healthcare being, equipped with
the finest hospitals in Asia along with excellent health
sciences and pharmaceutical educational institutions.
Good pool of pharmacovigilance and clinical research
professionals are available as Delhi National Capital
Region has some of the best Clinical Research,
Pharmacovigilance and other health sciences Institutes
and Training centres in India.
Presence of Regulatory Authority office (DCGI) in Delhi
confers a definite advantage for pharmaceutical
companies and clinical research organizations (CROs).
 IT Infrastructure & Data Security
Strong IT Systems, Servers & Processes
Well secured offices physical and electronic security
monitored 24x7
Internal server which is firewall protected
Round the clock monitoring to ensure security and
maintenance
Highest standards of data security measures are employed
Zero risk of data loss, pilferage or unauthorised access
24x7 power supply and power back ups
 Quality Systems
Think I systems, infrastructure, processes, IT are
successfully audited by global auditors
Internationally accepted, state of the art data handling
systems
Confidentiality agreements signed by all staff and
vendors
Think I has well defined, detailed, validated, audited SOPs
on all business processes, services, IT, data security,
administration, disaster management, business continuity
planning.
 Pharmacovigilance Services
Drug Safety Services
i. Single case processing
ii. Aggregate Reports
iii. Literature search and Review
iv. QPPV services and
Pharmacovigilance system master file
v. MedDRA coding
 Drug Safety Services
Post marketing Clinical safety reporting
Pharmacovigilance
Case Processing Case Processing( SAEs)

Expedited reporting Expedited reporting

(ICSRs)

Literature screening Clinical Trial Safety

PSURs Periodic reporting (ASRs)

Safety Signal generation and

assessment
 Drug Safety Services
Case Intake Case Processing Medical Distribution/
Assessment submission

Safety data Data entry Medical review Regulatory

Receipt submission

Duplicate MedDRA Coding Causality Ethics

check assessment committee
notification

Triage Narrative writing Individual ICSR Sponsor

Signal screening

Case Reviewing cases and QC, Create an analysis

Tracking Review case documents of similar events,
against source documents, Send to sponsor for
Query generation and 2nd line MR, if
forwarding necessary
 Drug Safety Services (Contd..)
Aggregate Reporting

Periodic Safety Update Reports (PSURs)

Periodic Adverse Drug Experiences Report (PADERs),
Development Safety Update Reports (DSURs) and
Periodic Benefit Risk Evaluation Reports (PBRERs)
Other Reports- Addendum reports, Summary Bridging
Reports (SBRs), SUSAR Reports, Drug Safety Reports
(DSRs) and Annual Safety Reports (ASRs)
 Drug Safety Services (Contd..)
Preparation and development of risk management plan, RMP
Preparation of Detailed Description of Pharmacovigilance
System
Literature Search and Review
Preparation of Pharmacovigilance System Master File (PSMF)
for the QPPV
MedDRA coding services
 Pharmacovigilance Consulting Services

Building a complete pharmacovigilance system for

pharmaceutical companies and CROs
QPPV/ LPVRP/LAR services in markets where it is required
Preparation of SOPs and other guidance documents
Writing and updating Reference Safety Information (RSIs)
Pharmacovigilance audits
Regulatory support and guidance
Pharmacovigilance corporate training programmes
Pharmacovigilance Consulting Services
(Contd..)
In addition to the services mentioned previously, we
also offer the following to Indian companies wishing to
enter the United States of America (USA) market
Pharmacovigilance audits
Inspection readiness
Setting up and managing the overall drug safety
infrastructure in the USA
Developing Standard Operating Procedures (SOPs) for
the pharmacovigilance processes
 List of QPPV/LPVRP services:
Function as a single point of contact between the regulators and MAH
Provide expertise in leading pharmacovigilance operations in the region
Collecting, logging, documenting and forwarding Adverse events (AEs), Product
Quality Complaints (PQCs) and Medical Information Enquiries, as needed
Communicate to Global Pharmacovigilance and facilitate the fulfillment of any local
pharmacovigilance obligations as per local health regulatory requirements
Forward all pharmacovigilance data to Global Pharmacovigilance and contractual
partners within the prescribed timelines and filing received acknowledgements
regarding this
Periodic Reconciliation of AEs with Central Processing Group
 List of QPPV/LPVRP services (Contd..)
Sending initial responses to Adverse Event/Product complaint reporter
Translation
Reviewing local health authority websites at periodic intervals for updates
Submission of expedited ICSRs and Aggregate reports to Regulators
Co-ordination for Safety data exchange agreements between MAH and
local contractors
Reporting Potentially New safety information/Crisis management to
Global Pharmacovigilance team
Maintaining the Local Pharmacovigilance Site File and associated
documentation
 Pharmacovigilance System Set Up
Gap Analysis, Preparing SOPs & WI s, PSMF, Imparting PV Training,
preparing SDEAs, Integrating QMS at Bliss with the PV System

Most of this information prepared, could be used for several other marekts
with some minor changes
Our Packages
Tier 1: Case processing on client database
Tier 2: Case processing and safety database of Think I
Tier 3: Case processing on safety database of Think I and aggregate reporting
Tier 4: Case processing on safety database, aggregate reporting with Signal Detection and Risk
management
 Corporate Training Programmes

Think I certified team of trainers ensures a focus on

constant training and retraining of its staff.
Team Think I is rich in experience, qualification and
stability.
We have a good pool of well trained and certified
professionals with medical, dental, life sciences and
Pharmacy backgrounds.
 Pharmacovigilance Training
Think I corporate pharmacovigilance programmes are designed to
provide comprehensive yet cost effective training solutions to the
client needs.
All programmes have been prepared in consultation with industry
experts and cater to the live industry scenarios.
Programmes can be delivered at the client site or in an online mode.
Suitable for beginners as well as mature PV companies.
 Pharmacovigilance Training
1. Understanding pharmacovigilance systems
Regulations in Pharmacovigilance
This section would cover international regulations and applicable local regulations as per
client requirements
Setting up a pharmacovigilance system
Qualified Person for Pharmacovigilance (QPPV) and their importance

2. Spontaneous case processing

Receipt and handling of spontaneous reports including narrative writing
Expeditable and non expeditable reports
Medical Evaluation
Quality Checks
Electronic submissions
 Pharmacovigilance Training
3. Handling study reports
Introduction to clinical studies and receipt of study reports
Handling solicited and clinical study reports
Narrative Writing
Medical review and SUSARs (SUAs)
Investigators Brochures and their significance
Blinded clinical trials- PV considerations

4. Literature search and review

Regulations, Databases, review and case entry
Aggregate reporting requirements
Risk Benefit Assessment
 Pharmacovigilance Training
5. Aggregate Reports
Roles and responsibilities
Types of aggregate reports
Content and format
Quality control and distribution

6. Signal detection, assessment and risk management plans

General considerations
Sources of signals
Detection and assessment
Risk assessment and minimization
 Pharmacovigilance Training
7. Guidance documents in Pharmacovigilance
Types of guidance documents
Importance and scope of SOPs and WIs

8. Reference Safety Information

Types of RSIs
Role and Importance
Review of and updating RSIs

9. Pharmacovigilance Audits and Inspections

Introduction and relevant guidance
Audit preparations
Audit findings and CAPA
 Safety database solutions
Think I partners with AB- Cube Solutions France
AB Cube provides cloud based software solutions for vigilance in Human
Drugs, Medical Devices, Cosmetics, Nutraceuticals and veterinary
products.
Cost effective
User friendly
Fully validated for quick, easy import, entry and electronic submissions
of adverse events.
Key features of our safety solution
Unlimited number of users with one time
implementation cost.
Safety solutions are FDA 21CFR part 11, E2B (R3),
HL7 compliant
Validated according to GAMP 5 (Good automated
manufacturing practices), full validation dossier
provided.
Generation of PBRER and Signal Detection.
Extensive support 24/7 & Training on database
through e- learning, virtual and Face to Face
Licence : 4 packages = 4 levels of
BASIC
Services
PROFESSIONAL BUSINESS ENTERPRISE
Software Full Functionalities
Functionalities
Unlimited number of users
Standard Validation Dossier
Online Access to documents
Free upgrades for latest
functionalities & compliance
Healthcare Certified Hosting
(HADS)
Technical Support Through Tickets Monday Friday Monday Friday 7/7 7/7
support & user 9:am-6:pm 9:am-6:pm 9:am-6:pm 24/24
assistance Support by phone
Max. number of Key users 1 2 3 5
Answer time 5H 4H 3H 2H

Included Options quoted on demand

Implementation & Training
BASIC PROFESSIONAL BUSINESS ENTERPRISE
Implementation Same price

The Implementation cost remains the same regardless of the level of service chosen

BASIC PROFESSIONAL BUSINESS ENTERPRISE

Training eLearning

Virtual
Face to Face

Included Options quoted on demand

Additional available options
BASIC PROFESSIONAL BUSINESS ENTERPRISE
Gateway

Provider Audit

Migration

Validation assistance

Specific Development

Set up Assistance

Inspection preparation or assistance

Installation On-Premise

Options quoted on demand

Different options are available depending on the level of service chosen
 Argus safety
We are also official license partner for Argus Safety and we provide database for
carrying out pharmacovigilance activities in:
Case Entry / Book In / Case Triaging
Data Entry
Medical Review
Aggregate reporting (Line Listings , Summary tabulations)
 The Leadership Team
Our leadership team consists of experts from the field of
pharmacovigilance, clinical data management, clinical operations and
corporate training.
Total 100+ man years of combined experience in their fields of expertise.
Capability to perform tasks from our site as well as client site.
Think I is led by an impressive group of executives with hands-on expertise
in safety, medical and regulatory affairs, and project governance. All have
experience in guiding global organizations to function as a unified team.
 Our Values
Quality
We ensure quality in our processes, data integrity and
excellence of deliverables.
Customer Focus
Our team at Think I are dedicated to satisfying the
needs of our customers. We believe in creating and
sustaining global standards of service that gains us
customer trust and confidence.
 Our Values (Contd..)

Knowledge
We are always open to learn, unlearn and re learn
from all sources. Knowledge sharing is important to
us and is encouraged.
Commitment
Our primary commitment is to our clients and to our
Employees and Clients and we aspire to cater to the
highest of their expectations.
 Our Values (Contd..)

Trust
The cornerstones of our business are honesty and
integrity. Thus, we aim to cultivate and nurture long
term relationships with all our stakeholders.
Continuous improvement
We believe in continuous improvement of our
technologies, procedures and the results we deliver to
our customers.
Our Team has

VISION
DEDICATION
QUALITY
EXPERTISE
CONTINUITY
It would be our pleasure to hear
from you
Business Development
Think I
C-101, First Floor
Sector 2
NOIDA 201301
India

Email : bd@thinki.in
Website : www.thinki.in
Phone : +91 98100 68241