5020- A, Sec 38 (W) Chandigarh | indivirtus

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

2. ABOUT US Indivirtusis 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: • Pharmacovigilance • Health Economics and Outcome Research (HEOR) • Regulatory Writing • Toxicology Writing • Scribing • Insurance billing

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. REGULATORY/Medical 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).

9. 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.

10. EXPERIENCED AND DEDICATED TEAM • Indivirtus ensures total client satisfaction with the state of art facilities and fully secured migration framework for Pharmacovigilance, HEOR, Medical billing , Insurance claim processing. • Our team is highly experienced working for 2-8 yrs. with renowned names in different service providers. • The team comprises of HEOR Exters, Pharmacovilance Associates, Quality Reviewers, Drugs Safety Physicians and Authors who can do complete documentation using high end hardware and software (R, ARGUS 8.1, Med Dra 20.1, Webex etc. to provide speedy solutions. • Therefore, we provide cost effective, customizable, user friendly, regulatory compliant safety database with completely auditable PV functionality.

11. What is Pharmacovigilance? Pharmacovigilance (PV or PhV), also known as Drug Safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products pharmakon (Greek for drug) vigilare (Latin for to keep watch) Why do we collect safety data in trials? • Compulsory: Regulatory requirement/ embedded in law • Good quality safety data improves the accuracy of prescribing information

12. NEED & OBJECTIVES OF PHARMACOVIGILANCE Latest guidelines from IPC and CDSCO suggest that it is mandatory for all the marketing authorisation holders of Pharmaceutical products in India are required to compulsory have Pharmacovigilance activities for all of their products. http://www.ipc.gov.in/PvPI/pub/Guidance Document for Marketing Authorization Holders.pdf Objectives of Pharmacovigilance: • To detect serious risk during a clinical trial • To communicate risk to patients • To provide adequate information to investigators • To assess risk for risk benefit equation

13. Pharamcovigilance Reporting System • Pre-marketing/Trial Phase: • Suspected Adverse Event (SAE) reports to PV department • Annual reports - Development Safety Update Reports (DSUR) and Investigational New Drug (IND) Reports • Post-marketing/Approved Drug Phase: • Spontaneous reports (yellow card) • Periodic Safety Update Reports (PSUR)/ Periodic Adverse Drug Experience Report (PADER) Regulatory reports are of 2 types: Expedited ( to be submitted in 7/15 calendar days) 2. Aggregate (PSUR and DSUR)

14. What and How We Do? • Reporting Services: • Collection of ADR data- Data entry and Traige • Individual case handling- Case processing, ICSR medical review • Periodic Reports-PSUR/PBRERs, DSUR, Benefit risk assessment • Literature Review • Specialized Services: • Signal Management • Risk management plan • Risk-Benefit analysis • Regulatory compliance • Labelling updates • We perform all these task with complete PV system in place which includes qualified PV team, Phamacovigilance system master file, best Safety database and other software, SOPs and WIs.

15. of PV outsourcing Potential • A well implemented PVO program can drive significant benefit for the organization, including: • Converting fixed resource costs into variable, workload dependent charges • Reducing the number of resources to recruit, manage, and/or train • Increased business model and capacity flexibility • Improved efficiencies and Return on Investment (ROI) • Outsourcing provides well-documented cost benefits.

16. Contact us: upendra@indivirtus.com info@indivirtus.com +91-9814133808 Healthcare Services (P) Ltd.