Think I- Delivering cost effective & complaint pharmacovigilance

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Your Pharmacovigilance Health Sciences Services
Partner
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Overview
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ADR reporting
Safety contact centre
Medical Information
Your Pharmacovigilance Health Sciences Services
Partner
Data Entry
THINK I Services
Signal Detection
Case Processing
Take a look at our process flow
E2B Submission
Literature search
MeSH search
YOUR COMPANY
DSUR, SUSAR, ASR
Aggregate reporting
PADER, PSUR/PBRER , Addendum
Medical writing
White papers
Pharmacovigilance training
End to End PV training
Safety Database
Argus AB Cube
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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.

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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.

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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

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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).

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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

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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.

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Pharmacovigilance Services

• Drug Safety Services
• Single case processing
• Aggregate Reports
• Literature search and Review
• QPPV services and Pharmacovigilance system master
  file
• MedDRA coding

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Drug Safety Services
Post marketing Pharmacovigilance Clinical safety reporting
Case Processing Case Processing( SAEs)
Expedited reporting (ICSRs) Expedited reporting
Literature screening Clinical Trial Safety
PSURs Periodic reporting (ASRs)
Safety Signal generation and assessment
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Drug Safety Services
Case Intake Case Processing Medical Assessment Distribution/ submission
Safety data Receipt Data entry Medical review Regulatory submission
Duplicate check MedDRA Coding Causality assessment Ethics committee notification
Triage Narrative writing Individual ICSR Signal screening Sponsor
Case Tracking Reviewing cases and QC, Review case documents against source documents, Query generation and forwarding Create an analysis of similar events, Send to sponsor for 2nd line MR, if necessary
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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)

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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

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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

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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

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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

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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

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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

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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

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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.

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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.

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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

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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

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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

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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

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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.

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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
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
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Licence 4 packages 4 levels of Services
BASIC PROFESSIONAL BUSINESS ENTERPRISE
Software Functionalities Full Functionalities
Software Functionalities Unlimited number of users
Software Functionalities Standard Validation Dossier
Software Functionalities Online Access to documents
Software Functionalities Free upgrades for latest functionalities compliance
Software Functionalities Healthcare Certified Hosting (HADS)
Technical support user assistance Support Through Tickets Monday Friday 9am-6pm Monday Friday 9am-6pm 7/7 9am-6pm 7/7 24/24
Technical support user assistance Support by phone
Technical support user assistance Max. number of Key users 1 2 3 5
Technical support user assistance Answer time 5H 4H 3H 2H
Included
Options quoted on demand
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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
Training Virtual
Training Face to Face
Options quoted on demand
Included
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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
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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)

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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.

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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.

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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.

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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.

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Our Team has
DEDICATION
QUALITY
EXPERTISE
CONTINUITY
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It would be our pleasure to hear from you
Business Development Think I C-101, First
Floor Sector 2 NOIDA 201301 India Email
bd_at_thinki.in Website www.thinki.in Phone
91 98100 68241
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