Indivirtus Healthcare Services - Real Time Cost-effective Solutions for the Healthcare Industry

1. INDIVIRTUS HEALTHCARE SERVICES (P) LTD. 5020, Sec 38 (W) Chandigarh | www.indivirtus.com

2. Indivirtus is a CRO which offers real time cost effective solutions to healthcare industry. We help the healthcare professionals and industry to maximize their efficiencies in its core competencies while helping them grow their business. This helps you to remain focused to your key areas while outsourcing the work of following key areas to experts at Indivirtus and synergize your operations. Indivirtus ensures total client satisfaction with the state of art facilities and fully secured migration framework for Medical writing, Pharmacovigilance, Health Economics, Scientific Publications and Medical Communications, Clinical trials and Bioequivalence studies. Therefore, we provide cost effective, customizable, user friendly, regulatory compliant services and completely auditable PV functionality.

3. To be among the top ten globally competent medical and health economics consultants capable of providing timely and accurate solutions with highest integrity to delight our customers, while also providing a challenging and growth-oriented environment to our team of experts having a great sense of pride and achievement. VISION To facilitate our customers with quality outcomes and financial prudence by creating and nurturing a team of highly competent and innovative professionals, employing state of the art technology, by optimal utilization of human capital, with dedication to fulfil the needs of our valued customers and deliver complete customer satisfaction with precise finesse and excellence. MISSION Indivirtus is committed to excellence, to uphold the integrity of health economics and medical billing, to ensure world class quality and excellent customer service. We endeavour to achieve this niche position through constant innovation, up gradation and customer satisfaction while operating under an effective quality management system that fulfils the needs of our customers with cutting edge technology. QUALITY POLICY

4. INDIVIRTUS HEALTHCARE SERVICES, WHY? • Helps to maximize your efficiencies in its core competencies and helping you grow your business. • Helps you to remain focused to your key areas while outsourcing the work on medical reporting and billing to the experts and synergize your operations. • Have the state of art facilities and fully secured migrations framework for Medical Scribe and Medical billing. • Ensures total client satisfaction. • Highly experienced and dedicated team for complete documentation using high end hardware and software to provide speedy solutions.

5. INDIVIRTUS HEALTHCARE SERVICES - BENEFITS Improve business outcomes Provide real time reporting and data analytics 05 01 Provide value added services Reduce costs of operations 06 02 Enhance productivity Delight the customer 07 03 Optimize resources Reduce cost of hiring, burden of employees, their cost of training 08 04

6. POTENTIAL BENEFITS OF OUTSOURCING SERVICES • A well implemented service program can drive significant benefit for the outsourcing organization, including: • Converting fixed resource costs into variable, workload dependent charges, • Reducing the number of resources to recruit, manage, and/or train the staff, • Increased business model and capacity flexibility, • Improved efficiencies and Return on Investment (ROI) and • Well-documented cost benefits.

7. SERVICES OFFERED Environmental/Toxicological Services Regulatory Writing Scientific Publications and Medical Communications Pharmacovigilance Clinical Trials Health Economics and Outcomes Research Bioequivalence Studies

8. Environmental/Toxicological ServicesPDE (Permitted Daily Exposure) or ADE (Acceptable Daily Exposure) • The ADE (FDA) or PDE (EMA) is a substance-specific dose that is unlikely to cause an adverse health event, if an individual is exposed to this dose or to a lower dose every day for a lifetime. • ADE/PDE are based on scientific evaluation of all available pharmacological and toxicological data, generally set exposure-route specific, in particular for the parenteral, the oral and the inhalation route.

9. Need of ADE/PDEs in Cleaning Process validation • Acceptable Daily Exposure (ADE) • or Permitted Daily Exposure (PDE) or Threshold of Toxicological Concern (TTC) by scientific evaluation of all available pharmacological and toxicological data including both non-clinical and clinical data • Applicable to human & veterinary pharma, drug substance & drug product, commercial & supplies • Implementation plan in industry according to risk prioritization (type and use of products, market, new products, facilities,…) should be scientifically justified . The assessment shall be documented • in-writing. EMA Guideline on Shared Facilities(wef Jun. 2015) EU GMP Part 1 Chapter3, and Chapter 5 (wefMar. 2015) FDA 21 CFR 211.67 Equipment Cleaning and Maintenance(wef2011) EU GMP Annex 15 (wefOct. 2015)

10. Objective of ADE/PDE To ensure the safety of human patients and target animals exposed to residual active substances via medicinal products as well as consumers potentially exposed to residual active substances present in food of animal origin as a result of treatment of food producing animals with veterinary medicinal products in which residual active substances are present. Aim is to recommend an approach for deriving a scientifically based threshold value for individual active substances to be applied for risk identification.

11. Occupational Exposure Limit (OEL) Acceptable airborne concentration for worker exposure OELs for the protection of workers have been around at least since 1939 when the American Conference of Governmental Industrial Hygienists (ACGIH) published its inaugural acceptable workplace exposure limits (now known as threshold limit values, or TLVs). Some sub-population of workers, due to individual susceptibility, may be adversely affected at concentration at or below the OEL. Sometimes developed to protect even sensitive subgroups, e.g., women of child bearing age, asthmatics. Developed when a drug reaches significant manufacturing amounts or critical FDA stages

12. REGULATORY WRITING NONCLINICAL SERVICES • Nonclinical modules of Common Technical Document (CTD): nonclinical study reports (Module 4), nonclinical summaries (Module 2.6) and nonclinical overviews (Module 2.4). • Determination of health based exposure limits: Permitted daily exposure (PDE), Occupational exposure limit (OEL) and Occupational exposure band (OEB). • Toxicological assessment reports: toxicology profile for cosmetic ingredients, cosmetic product safety report (CPSR), safety/risk assessment of drugs, fragrances and flavours and ingredients used in formulations or consumer products. • Safety Data Sheets (SDSs).

13. MEDICAL WRITING CLINICAL SERVICES Clinical trial documents: Investigator’s Brochure, Protocol, Informed Consent Form, Case Report Forms, Statistical Analysis Plan, Clinical Study Report etc. Clinical modules of Common Technical Document (CTD)/Dossier: clinical study reports (Module 5), clinical summaries (Module 2.7) and clinical overviews (Module 2.5). Clinical Evaluation Reports for Medical Devices. Others: Drug Labelling, Biowaivers, Clinical trial waivers and GAP analysis of dossiers – clinical sections.

14. PHARMACOVIGILANCE SPECIALIZED SERVICES • Signal Management, • Risk management plan and • Risk-Benefit analysis. • ADR REPORTING SERVICES • Individual Case Study Reports (ICSRs), • Literature Review and • Periodic Reports: Periodic Adverse Drug Experience Report (PADER), Periodic Benefit Risk Evaluation Report (PBRER), Periodic Safety Update Report (PSUR), Developmental Safety Update Report (DSUR) and Annual Safety Reports (ASRs).

15. HEALTH ECONOMICS AND OUTCOMES RESEARCH Systematic Literature Review Focused Literature Review Meta-analysis Network meta-analysis (ITC) Publication support

16. HEOR SERVICES • Model development • Sub-group analysis • Meta-Regression analysis • Sensitivity analysis • Report writing and publication support • Model development (Frequentist and Bayesian approach) • Scenario analysis • Net-Meta regression

17. SCIENTIFIC PUBLICATIONS AND MEDICAL COMMUNICATIONS • SCIENTIFIC PUBLICATIONS • Manuscripts, Abstracts and Posters • Global and Regional Publication Plans • Review Articles • Systematic Reviews and Meta-Analyses • MEDICAL COMMUNICATIONS • Marketing product slide decks/Visual Aid • Subject expert committee documents for DCGI/Summary document

18. SKILLEDTEAM A team of passionate and dedicated professionals at Indivirtus is equipped with following skills: Domain knowledge • Substantial knowledge of varied therapeutic areas, regulatory/scientific guidelines and key statistical concepts. Knowledge of audience • Understanding of the target audience, i.e. regulators, scientists, doctors, or pharma, life sciences and healthcare companies. Writing skills • Logical and succinct style of representing data supported with accurate interpretation.

19. SKILLEDTEAM Data integrity • Maintaining accuracy, consistency and security of data – using stringent document management systems. Literature search • Using well-planned search strategy, appropriate keywords and a variety of sources when reviewing literature. An independent outlook • Performing critical content reviews, correctly interpreting results, identifying potential limitations and discussing unexpected findings.

20. SKILLEDTEAM Clarity • Establishing clear objectives to organize ideas and embrace creativity.  Keeping updated knowledge • At par with new relevant information, undergoing regular training programs to enhance their skills. Interpersonal skills • Well-honed verbal, non-verbal and listening skills for problem solving, negotiation and decision-making. Project management skills • Highly organized, proactive, respectful of metrics driven timelines and accepting accountability & responsibilities for quality.

21. Contact us: upendra@indivirtus.com veena@indivirtus.com +91-9814133808 www.indivrtus.com