remedying clinical research woes - hcl technologies · clinical operations and data management...

Why Drug Discovery Equations are Going Wrong?

Reaping the Benefits

Why HCL’s CRO Services?

“It's great working with you. Please extend a big thank you to all HCL employees providing services to the project. It's a great achievement and we are looking forward to working with you to make the project a great success story.”

- Director“It’s a great professional and human opportunity to work with HCL! Thank you for all your support.”

- Italy Process Steward

“It gives me great pleasure to acknowledge that it was a satisfying experience to work with the MW, Clinops & DM teams of HCL technologies. HCL not only has an outstanding medical writing group but also has an equally dedicated and passionately driven clinical operations and data management team.An absolute pleasure to interact & work with HCL Technologies Ltd.”

- Deputy General Manager,Medical Services

IT SpecialistWithIn-HouseCRO

from MDs,Biostaticians,Data Managersto ResearchAssociates

SavingsOffered inOperationalCosts

40%Per YearSavings oneach Study

$3MnProven TrackRecord WithOver 150Clinical Trials

Years12+

HCL’s Life-Sciences METHODOLOGY

HCL’s CRO Services

Only Teamof Experts

Partnerships forQuicker Approvals

and RegulatoryCompliance

Quick Setup andLocalization of

Trial Efforts

Multi-PlatformData Management

Expertise

Six Sigma basedQuality Control

Procedures

Complex GlobalRegulatory and

ComplianceGuidelines Hard to Maintain

Data Quality& SanityBurgeoning

Clinical TrialCosts

Capital IntensiveClinical Research

Practice

Retire &Extend

Discover Optimize Pre-Clinical

PlanningStudyManagementCloseout Implementation

MarketResearch

Publishing &Submission

MMA andNDA support

Coordinate Launch

PatientSupportProgram

GMP (GoodManufacturingPractice)

NewMarketApprovals

Quality Assurance CAPA

Start-up

Quality Control

Technology Transfer & Support

eCTDSupport

DrugDevelopment

RegulatoryApproval

QualityManagement

Compete for generics Prepare Drug Extensions

ProductLaunch

DrugDiscovery

RemedyingClinical Research Woes

HCL - Key Focus Areas

HCL creates ‘shared services’ across 7 locations for a Global Pharma client, to bring about process standardization and transformation.

Few Highlights of our achievements in Pharmaceutical and Medical Device Services area:

CommercialProduction

Clinical DataManagement

MedicalWriting

Drug SafetyServices

RegulatoryPublishing andSubmissions

Risk-BasedMonitoring

Core Offerings

For a large Asian Pharmaceutical Company