1. Xylem Clinical Research Pvt. Ltd.A Site Management Organization for Phase I-IV Clinical Trials

2. Snapshot India With population of more than 1 billion and annual average GDP growth rateof 5.8 %, India is among the fastest growing economy of the world. India has 300 universities, over 750 graduate and post-graduate programsand about 50 million College graduates. The nation constitutes the worlds second largest labor force with 516.3million people. Growth rate of Indian healthcare industry is about 12% per annum, withcurrent size of US$ 35 billion, it is expected to become US$ 280 billionindustry by 2022. 3. Prevalence of Various Diseases in India Hypertension: 160 millionAsthma: 40 millionCVD: 35 millionDisease Conditions Diabetes: 34 million Tuberculosis: 10 million Epilepsy: 8 million India Fact File:Population: 1 billion HIV/AIDS: 4.2 millionLife expectancy: 62 yearsHospitals: 15000+ Cancer: 3 millionDoctors: 500,000+ Alzheimers Disease: 1.5 millionEstimated No. of Cases 4. Therapeutic Area of Clinical ResearchCancer: 21% Infectious Disease: 16% % of Clinical Trials Diabetes: 15%CVD: 14% Respiratory: 13%CNS: 7%Others: 14%Therapeutic AreaSource : ClinicalTrials.gov 5. Phase-Wise Distribution of Outsourced Clinical Trials Others: 10.3% Phase-IV: 9.7% Phase-I: 8.8%A total number of 1494 clinical studies have been enlisted in India till Dec 2010, with 491 studies currentlyin the enrolment phase.Phase-II: 22.6%Phase-III: 49.5%Source : ClinicalTrials.gov 6. Need for SMO The complexity of clinical trial execution and need for quality assurance isincreasing day by day making it difficult for PIs to execute them along withroutine clinical practices. New investigator sites are not well-versed with the clinical trial processhence generally requires SMO support. Pharmaceutical companies and CROs are seeing SMOs as strategic partnersfor the success of their projects. Increasing attrition rate at trial site(s) hampers the execution of clinical trialshence SMOs are becoming crucial for the smooth execution of trials. Sponsor/CRO are relatively unaware of new but potential investigator sites,hence they involve SMOs to recommend site to them. 7. About Us Xylem has been established to act as a common platform between the Principal Investigator(s) and Sponsor/CRO(s) for the smooth execution of clinical trials. The team of Xylem brings more than 50 years of cumulative experience in Clinical Research.Investigator SponsorLooks for meaningful trials Looks for potential investigatorsRequires support to carry out pre- Requires support to carry out pre- trial, during-trial and after-trialtrial, during-trial and after-trialactivities Xylem activities Focus more on medical care of study Focus more on smooth and quality participants than the management ofconduct of clinical trial at the sitetrial logisticslevelRequire help in negotiating the trial Require 100% audit readiness atbudget based on protocol scheduleany time-pointand logistics 8. Our ServicesSMO SupportSite Coordinator SupportOur servicesMedical and Regulatory Regulatory SupportWriting 9. Our Services1. SMO Support Review of site facility, resources, source documentation practices, ECs SOP etc.and up-scaling (as and where required) to meet the ICH-GCP and applicableregulatory requirements (Schedule-Y). Identification and development of potential Principal Investigator(s) (PIs) Assistance in the execution of Undertaking by the Investigator (Appendix-VII ofSchedule-Y), Form FDA 1572, Financial Disclosure, Clinical Trial Agreement etc Communication with study Sponsor/CRO Translation and validation of ICF in required vernacular language(s) Preparation and submission of EC dossier and follow-up on queries (if any) Development of site specific SOPs 10. Our Services Meeting the project timelines for patient enrolment and data managementmatrices Meeting the highest quality matrices for protocol compliance, patient follow-up, safety reporting, IP accountability, CRF completion (paper/e-CRF), andcompliance with ICH-GCP and applicable regulatory guidelines Facilitate the monitoring visits by keeping all the essential documents up todate thereby reducing the monitoring time by 50% Turnaround time of 24 hrs for any urgent queries from study Sponsor(s)/CRO(s) Periodic reporting to EC (SAEs, safety alerts, protocol deviations, trial progressetc.) as stipulated in the approval letter Keeping investigator sites audit ready at any time-point 11. Our Services2. Site Coordinator Support Appointment of site coordinator for smooth execution of the trial incompliance with protocol schedule of events and applicable regulatoryguidelines.3. Medical and Regulatory Writing Development of essential trial documents (Protocol, ICF, IB, CRF etc.) Preparation of manuscripts, abstracts, posters, research communications etc Preparation of CSR and other study reports 12. Our Services4. Regulatory Support We at Xylem provide regulatory assessment and strategies for timelysubmission and approval. Consultation on Indian Regulatory Guidelines Review, compilation, submission, and follow-up of Regulatory dossiers Safety Reporting 13. Xylems Advantage Timelines Project MilestonesWithout Xylem With XylemCompletion of Feasibility Questionnaire3-4 weeks < 1 weekCompletion of CDA, Undertaking by the Investigator, Form FDA 3-4 weeks 1 week1572, Clinical Trial Agreement (CTA) etc.EC Submission1-2 weeks < 1 weekReview of appropriateness of EC approval with regards to thedocuments and version reviewed and approved, fulfillment of -1 dayquorum requirements, recommendations etc.Meeting the project timelines with regards to data management May or may not Always on planmatriceson planMeeting the quality matrices with regards to protocol compliance, May or may not Always on planpatient follow-up, safety reporting, IP accountability, CRF on plancompletion (paper/e-CRF) and compliance with ICH-GCP andapplicable regulatory guidelinesSite audit ready at any time-point May or may notAlways on plan on plan 14. Xylems StrengthsClient- centric approach 100 % error reportingQuality execution alongAudit readiness at any with ethical and scientificgiven time-pointexcellence 15. Therapeutic Area ExperienceOncologyEndocrinologyInfectious DiseasesObstetrics and GynecologyGastroenterologyENTPsychiatryHematologyOrthopedicsInternal Medicine 16. Trial SitesOur trial sites are located in Pune and Delhi/NCR region. A few of our sites wherewe have site management experience include Nobel Hospital, Pune Poona Hospital, Pune Ruby Hall Clinic, Pune Deenanath Mangeshkar Hospital, Pune Sahyadri Hospital, Pune Fortis International Oncology Group, Noida 17. Case StudiesOne of the sites provided by Xylem for a Phase III study on NSCLC having highlystringent inclusion/exclusion criteria was successful in enrolling 12 patients. The Xylemsite has been the global highest recruiting site for the study.One of the sites managed by Xylem was a rescue site for Phase III study in UlcerativeColitis, and was activated just 2 months before close of enrollment. Despite havingvery limited time for enrollment as compared to other sites, Xylem site enrolled 14patients, and has been amongst the few high recruiting sites. 18. Case StudiesFor a Phase III study on newly diagnosed SCLC (a rare indication), India was an add oncountry. By the time, Indian sites were activated only 2 months were left forenrollment. Xylem site was successful in screening three and randomized one patient;whereas the other Indian sites could hardly screen a single patient. Xylem site hasbeen the only recruiting site from India.All the studies conducted at Xylem sites have been audited by independent auditorsappointed by sponsors. Xylem staff has been appreciated for the high quality workwith no significant violations. All the managed sites have been found audit-ready atany given time-point. 19. Case StudiesXylem site team has received appreciation for good protocol compliance, meetingstudy timelines, compliance with regulatory guidelines, high subject retention, andgood subject follow up for the managed studies. 20. Our TeamOur core team comprise of highly competent and experienced clinical researchprofessionals having a rich experience of conducting phase I-IV clinical trials forIndian as well as International Sponsor(s)/CRO(s). The team of Xylem brings morethan 50 years of cumulative experience in Clinical Research. The team is equippedto achieve service excellence under the able guidance of Dr. Shruti S Inamdar(Head Operations) and Dr. Soneera Arya (Associate Director) 21. Contact UsGurgaon Office Pune Office Dr. Soneera Arya Dr. Shruti S Inamdar Xylem Clinical Research Pvt. Xylem Clinical Research Pvt. Ltd. Ltd.G-29 South City I, Behula 103, BT Kawade Road,Gurgaon, Haryana(122001) Ghorpadi, Pune 411 001Ph: +91-124-4223379M: +91-9860011620; M: +91-9718306565E-mail: shruti@xylemcr.comE-mail: soneera@xylemcr.comWebsite : www.xylemcr.com Website : www.xylemcr.com