1Healthcare Services Group including Clinical Trial Services Exclusively through GCP-MB, LLC
2Contents Corporate Background 3 IDS Infotech’s Healthcare Services 5 Our CapabilitiesSelect Case StudiesIDS Infotech’s Best Practices
3Corporate BackgroundTwenty years of successful management in IT and Business Process OutsourcingEstablished in 1989, IDS Infotech employs over 1200 peopleOffices in 6 locations globallyLocated in Chandigarh, Mohali and New Delhi (Noida), India, IDS is one of the largest Back Office Processing Units in North IndiaSubsidiary - IDS America, Inc. founded in 2004 with offices in NY and VirginiaSupport Office in the UK with additional Multi-location facilities in India as a part of Business Continuity Plan (BCP)IDS Infotech uses a seamless global delivery network and extensive domain expertise to help any type of business achieve rapid and sustainable cost savings, improve cash flow and drive top-line growthIDS applies the latest technological advances, a highly educated workforce and total customer commitment to provide cost-effective solutions to our clients around the world
4Engineering and Design Content Management and Publishing Solutions Global Service Areas: Our experts successfully migrate processes—with quantifiable results—in the following service areasIDS InfotechHealthcareEngineering and DesignLegal ServicesContent Management and Publishing SolutionsSoftware ServicesProvides complete healthcare business solutions around the globeCaters to provider, payer, and pharmaceutical segmentsServices include clinical data management, medical transcription, accounts receivable management, electronic medical records, insurance & customer careHIPAA compliant and ISO 9001:2000 certifiedCaters to diverse industry verticals such as automotive, aerospace, and machineryServices include Engineering Design, Engineering Analysis, CAD services, and Manufacturing SupportRelationship management by local (EU & USA) engineering personnelDomain & sub-domain expertise in all industry verticalsValue Analysis/Value Engineering across the product life cycleOffers Client-dedicated teams, Six Sigma processes and leading edge world-class technologySpecializes in ESI processing, Document review, legal research, and paper discoveryCaters to corporations, law firms, and e-discovery AlliancesExpert team includes certified ESI processors, Attorney reviewers, project managers, and litigation analystsSpecializes in content management and pre-press services such as data capturing, data conversion, typesetting, and document scanningCaters to the production and conversion needs of publishers, knowledge service providers, professional organizations and universitiesServices range from editing books to academic and financial publications involving high volumes of mathematical and tabulated dataCaters to diverse sectors, including Retail, e-Commerce, Network security, Healthcare, Media and Entertainment, and ISVsServices include application development and maintenance, Technical helpdesk, QA and testing servicesExpertise in technologies such as .Net, Java, LAMP, iPhone and in designing and developing Rich Internet applications
6We offer end-to-end Healthcare services across the entire value chain, thus adding higher value to our clientsIDS Healthcare Solutions across the Value ChainAppointment SchedulingInsurance Authorisation and Pre-certPatient Call AnsweringClinical Research Data ManagementCodingReceivable follow-up and CollectionsBilling and ClaimsCharge ProcessingMedical TranscriptionPatient Record Secure storage and retrievalAccount Receivable ManagementSpecialised servicesPatient Records ManagementPatient Records and EMRFront Office
7Our healthcare services Provider SegmentMedical Transcription Services (MTS)Account Receivable Management (ARM)Medical Record Digitization / Electronic Medical Records (EMR)Payer SegmentInsurance Services Group (ISG)Pharmaceutical ServicesClinical Data ManagementDirect-To-Customer Services
8We cater to the provider, payer and pharmaceutical developer segments Clinical Data Management (CDM)Clinical Data Management and SAS Programming services to Pharmaceutical Research Companies through GCP-MB, LLC, providing both clinical and non-clinical servicesDirect-To-Customer ServicesDrug Information Services, Product Complaint Services, Drug Ad Response Hot line, Market Research, Patient recruitment and screening for Clinical ResearchPharmaceutical SegmentProvider SegmentAccount Receivable Management (ARM)Appointment Scheduling, Patient Registration in Practice Management System, Patient coverage and Benefits verification, Coding, Charge Entry, Claim submission, Payment posting, Denial/Rejection Analysis, A/R Follow-up, Provider credentialing, and pre-adjudicationMedical Transcription Services (MTS)Medical Transcription Services to US Hospitals and MTSOsMedical Record Digitization / Electronic Medical Records (EMR)Online patient registration, medical template customization, data conversion dumping from old system to new system, medical records day-forward conversion, and medical records backfile conversion for EMR systemPayer SegmentInsurance Services Group (ISG)Data Entry of insurance claims for insurance companies and TPAs
9Our experience in Clinical Data Management (CDM) Clinical Trial Experience in Depression, Oncology, Psoriasis, Rosacea, Periodental disease, Lupus, HHID, Liver failure, Asthma, COPD, Hypertension, Analgesics, etc.Dedicated experienced project manager for each account with over seven years of experienceTeam of twenty people who have expert knowledge in medical terminology and coding methods with average experience of 3-4 yearsProcessing at an average 1000 records per day per person for clinical and non-clinical projectsSuccessfully delivered several complex projects well within expected budget and turn around timeFully HIPAA Compliant process
10Our Process Flow Chart for Clinical Research Management
11Our experience in Direct-To-Customer Services For PatientsAssist patients in better understanding the drug by answering their questions on drug usage, side effects and any other issuesCreate database of prescribers, users, target patientsServe as help desk for consumers, information collection desk for marketing divisionDrug Information ServicesFor PhysiciansServe as the first level resolution center, answering questions around: appropriate therapy for specific patients; adverse reactions to drugs; efficacy of drugs; drug interactions; intravenous additive incompatibilities; biopharmaceutic and pharmacokinetic parameters of drugs; dosing in renal failure; appropriate therapy for a disease state; identification of foreign drugs; and information on new drugsProduct Complaint ServicesLog in the received complaintFilter the complaint into critical or non-critical categoriesAddress non-critical complaints and escalate critical complaints as per protocols setFollow-up on the resolution with the complainantDrug Ad Response Hot lineThis hotline can be used for any of the following purposes:Answer clinical or Benefit questionsCollection of Patient interest dataClinical CounselingProduct education – for the product on active promotionMarket ResearchCollect Socio Economic StatisticsConduct patient Satisfaction survey’sConduct patient / physician Demographic surveyPatient Recruitment and Screening for Clinical ResearchScreen the patients for recruiting in clinical trials based on the inclusion and exclusion criteria
12We managed over 50 clinical and non-clinical projects Daiichi SankyoPain TherapeuticsViceptMitsBMSAcceleronNovartisBattelleAZ-NXYALS (Advance Life Science)GenzymeActelionAstellasPremierGPCARCAForestEisaiAMILigandCentocorPharmacyclicsAtheroGenicsHyperionDSPAHemispherxPGx HealthAllerganTraconNuvoPremier ResearchShireProlexysDuramedSyntaNeurogesXAuxiliumAZ-SeroquelAl PharmaEndoCeuticsPain TherapeuticXanodyneAZ CrestorPoniardPharmassetTMC CangrelorArca BiopharmPaciraGaldermaLux Biosciences
14Case Study for Clinical Research Management Client backgroundThe client is one of the largest global Clinical Research Organizations having footprint in 18 countries. Services support the entire drug development process cycle. Service offerings range from preclinical testing to clinical trials management (Phase I to Phase IV) thus assisting pharmaceutical and biotech companies of all sizes to fulfill their research and development, clinical trial, regulatory and marketing support needs.Project backgroundData entry of Case Report Forms (CRFs), as part of Clinical Trials Phase II and III, was expensive, time consuming, and created a bottleneck in proceeding to the next stages of review for the client. CRFs were being entered by the client at the client’s own production facilities. The client was looking for a way to eliminate the bottleneck resulting from the time consuming, low end 1st and 2nd pass data entry of CRFsChallenges faced by our ClientOur SolutionThe client, being a global operator, has a centralized online database and the service provider needed to have 24-hour access to this databaseIDS Infotech established fire walled VPN connectivity between the customer’s Oracle Clinical Database in the US and our operational facility in IndiaTo eliminate the bottleneck, the client established a minimum turn around target of 21 days to process a backlog of 11,500 formsAll 11,500 forms processed by IDS Infotech in 7days. Post processing efforts by the client was reduced significantly, as all manual discrepancies were resolved at 2nd pass entryBeing a Phase III clinical study requisite, audit trails were required to ensure client confidentialityA secure, US based server was used to transfer scanned CRFs (images) to India. All processes strictly followed the required SOPs dictated by the clientThe client utilized Oracle Clinical, which required specific application knowledge and operating skillsIDS Infotech core team working on this project was trained by CRO in UK on Oracle Clinical (OC)A T3 module created by the core team, with assistance from the client, allowed efficient transfer of OC skills to India based data entry personnelAdditional on-line training by teleconference and Web Cast was imparted to facilitate knowledge transfer, resulting in OC expertise with minimal investmentBenefits to ClientAccuracy: The accuracy of the delivered work was on average 98.5%Turn Around Time (TAT): The agreed upon TAT by the client to receive the indexed CRFs was 21 days whereas IDS Infotech delivered the same within 7 days as we have dedicated team at IDS Infotech to do CRF indexing exclusively. Currently the team is working with a TAT of three days and meeting the same consistently.Cost saved up to 40%: By using IDS Infotech personnel who are well trained to provide best of services there is no capital investment on infrastructure and resources from the client’s side, the total reduction in the cost of the client is as high as 40 %. We were able to provide solution to the client to reduce the costs involved in handling multiple databases as against a single database.
15Case Study: Our approach Phase 1: Process AssessmentPhase 2: Implementation of ServicesPhase 3: Quality AnalysisClient visit: IDS Infotech team visited the client’s site in the UK for three months in order to understand their processThe client also visited IDS Infotech in India and performed audit of the facility for the capability testing to perform clinical research related workWe were compliant with all the requirementsEstablished Clinical Data Management (CDM) processes at IDS InfotechTrained the IDS Infotech teamGained access to client’s application and database through secured user IDs and passwordsProvided the following services for the CRFs Phase I, II and III of the clinical trialsIndexingFirst passSecond pass of the CRFsQuality Management of the studiesPerformed data indexing of all the above mentioned studies, which is the step two in data entry of Phase I clinical trialsThe entire team at IDS Infotech was trained online for data indexingConducted Quality Management: QM is the final step in Clinical Database check. The main objective of QM was to ensure that the database is an accurate reflection of the CRF and the data review is appropriate and consistent with study guidelines and conventionsPost completion of data entry, released the CRFs, which in turn were saved in the client database for the Quality Analysis at their end
16Case Study for Clinical Research Management Client backgroundOur client is a leader in the electronic transformation of clinical R&D. They offer a suite of regulatory, clinical, process and IT solutions. They have a proven record of delivering innovative solutions to leading biotech and pharmaceutical companies.Our Service OfferingsReceived Case Report Forms (CRFs) and Data Clarification Forms (DCFs) for book marking and linking from the clientThe overview of steps is as follows:Case Report Forms (CRF) Book markingCase Report Forms (CRF) Linking to DCFQuality Check 100%Second stage Random Sampling QA processAssisted the client in both clinical and non-clinical projectsManaged over 50 clinical and non-clinical projects for the clientProject AchievementsDescriptionVolumes handled for Clinical projectsVolumes handled for Non-Clinical projectsTotal number of client projects:6830Total number of files (PDF):183061789Total number of pages (CRF):410954Total number of DCF / Bookmarks:DCFbookmarksTotal number of Queries resolved / Links:queries resolvedlinks
17Case Study for Clinical Research Management Client backgroundOur client is dedicated to serving the Pharmaceutical, Biotechnology and CRO Industries by developing and supporting state of the art software and services designed to facilitate a more efficient, effective and timely capture, distribution and analysis of clinical data from paper or imaged CRF forms. It offers the possibility of electronic data capture from paper or imaged CRF, including full verification, validation, data management and clean-up.Our Service OfferingsImage Verification for CRFsVerify the received images against online client dataData Entry – 1st and 2nd PassQuality CheckCheck all records100% by comparing the data entered in the 1st and 2nd pass to ensure quality SLAField Data Clarification Forms (FDCFs)Data entry of DCFs including query resolutionStatistical Analysis Systems (SAS) in Clinical trialsComplete analysis of the patient data deploying SAS toolsStatistical Analysis SystemsThe following steps are followed for performing Statistical Analysis in Clinical TrialsImport external dataData validationData analysisReport generation
18Case Study for Insurance Services Client: Third party Administrator The client is a leading Third Party Administrator and principally engaged in administering self funded healthcare plans for 300+ lives, single or multi-site employers and back shop claim processing. The client is responsible for the administration of an employer’s medical benefit plan. They are also responsible for printing and providing ID cards and medical benefit plan booklets, as well as processing and arranging for payment of medical claims.Project BackgroundChallenges faced by ClientThe client was looking for a partner who could help them to perform the digitization of about 3000 medical claims per day. The client wanted to engage cost effective service providers which can meet the expected TAT of 12 hour for these claims with at least 99% accuracy. IDS conducted detailed study of their requirements and undertook the pilot for the project.The major challenges were to :Cut on the paper printing cost.Output in HIPAA 837 format. 3).Achieve the turnaround time with the expected 99% accuracy levels.Our SolutionThe IDS in-house training team developed a fast track training program for the data entry personnel, and ramped up staff into its dedicated facility to the required number on an accelerated pace.Key processes were optimized to maximize productivity from the staff and all the team members were adequately trained and tested before putting them on the project.To meet the TAT requirements of our client, a special application was designed where we could open the client input files on the upper half of the screen and index the data in our application in the lower half of the screen. Also this application recorded all the entries made and auto-populated the recurring data. This saved a lot of time and increased the productivity of our team members. Also, we did not have to print all the input data received from the client.100% quality sampling was done during the initial 2 weeks to understand the weak areas of the team and retraining sessions were conducted to improve on them.Daily feedback sessions with the client were conducted during the pilot phase to ensure customer satisfaction.Benefits to ClientClient appreciated the performance during the pilot phase. They were particularly happy with the quick turnaround and the quality work.Client gained the confidence on IDS, and they doubled up the volumes in 45 days.Client started seeking solutions from IDS wherever they required our services that required any special treatments.Cost Saving: The outsourcing concept resulted in huge cost savings to the client as otherwise they were getting the digitization done domestically which incurred heavy costs compared to the off-shore digitization.
20We differentiate ourselves by following best practices in all our processes Our best practicesSecurity and ComplianceGlobal client requirementsHR policiesQuality and SLA requirementsProject Management
21Our best practices We follow a zero-tolerance security and compliance policy Confidentiality &Data SecurityPersonnel LevelTechnology LevelPhysical SecurityEach employee is trained on the Confidentiality and monitored for any data exchange, either physical or virtualWe have all the necessary security features to ensure all data is not only protected, but stored with a Business Continuity Plan.We have a mirror site with NTT Vario with full fledged secure servers and systemsAll locations secured by Security and Electronic controlsHIPAAPersonnel LevelTechnology LevelContract LevelCompliance OfficerAll IDS Infotech employees in our Healthcare division undergo a HIPAA Compliance training Program and evaluated. Those that pass only can work with clientsWe request for a HIPAA compliance checklist from the client.Check list signed off once technology requirements are metAll locations secured by Security and Electronic controlsDedicated Compliance officer for HIPAA
22Our best practices We understand Global Client requirements No Downtime – Guaranteed 24x7 operations100 percent link redundancy including Last mile local loop5 Mbps Bandwidth with VPN - Easily scalableFacility wide and inter facility level BCMData security audit process; ISO company; 100% data back upOwn US based secured, dedicated FTP, and web serverClient confidentiality - NDA; firewalls at gateway/ remote server
23Our best practices Our staff and HR policies have yielded lower than industry attrition rates Strict adherence to Indian government rules for employee welfareStaff covered under group medical insurance schemeEthical workplace practicesNo employee below 18 years of ageStructured reward/recognition and performance appraisal systemEmployee work place as per international standardInduction and on-going functional trainingContinuous feedback and improvement mechanism
24Our best practices We guarantee Quality and Turn Around Time (TAT) SLA requirements ISO 9001 certified QMSIdentify KRA in joint review with clientProcess based, data intensive approach based on DMAICWell-documented SOP’s for maintaining project qualityEach SOP with clearly defined tasks and control pointsEach task staffed with trained staffEach task with well defined performance and quality metrics100% QA to client. No dispatch to client without Quality CheckMIS to track and deliver TAT – within 24 hours or more
25Our best practices We follow a least pain to the client, project management based migration approach Establish Team Charter; understand business rulesProcess a sample; analyze client requirementsTranslate in terms of project resource requirementsPresent solution costing to client; sign SLASetup process requirementsPhased approach: run a Pilot; tune process; incorporate improvements; continue phased ramp up till ownership of full volume; MIS system for reporting & communication
26We have been certified for providing top-most quality while maintaining security and confidentiality ISO9001:2008ISO27001:2005HIPAACOMPLIANTAS9100:2001QUALITYThe ISO 9001:2008 standard provides a tried and tested framework for taking a systematic approach to managing an organization's processes so that they consistently turn out product that satisfies customers' expectations.SECURITYISO/IEC formally specifies a management system that is intended to bring information security under explicit management control. Being a formal specification means that it mandates we meet specific requirements.CONFIDENTIALITYHIPAA establishes standardized mechanisms for electronic data interchange ( EDI ), security, and confidentiality of all healthcare-related data. The Act mandates security mechanisms to ensure confidentiality and data integrity for any information that identifies an individual.QUALITYThe standard adheres to all the requirements of ISO 9001:2000 plus additionalrequirements for the aerospace industry.
27Safe Harbor Privacy Principles IDS consider protecting the integrity and privacy of every confidential information as a crucial part of our services. We have strict directives for Safe Harbor Privacy principles and our security and policies are revised from time to time for better scrutiny and privacy maintenance. With every such amendment, changes are made in the processes and the technology so as to make both compliant.
28Our Clinical Trials support services are offered exclusively through GCP-MB, LLC. For other services we can be contacted at…USA OfficeIDS America Inc.1501 Broadway, 12th FloorNew York Tel : (+1) Fax : (+1)India OfficeIDS Infotech Ltd.C-138, Phase VIII,Industrial Area, Mohali, India.Tel : +91 (172) /602Fax : +91 (172)Europe OfficeIDS Infotech Ltd. Croy LC EindhovenThe NetherlandsTel : +31 (0)Fax : +31 (0)This document details information and methodology of a confidential nature given by IDS Infotech. No part of this document can be used, reproduced or disclosed to any third party without the written prior consent of IDS Infotech.