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