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Genelife Background
The company was established with an initiative to provide clinical research services with assured high recruitment rate and quality data.
The company was founded at Mumbai in February 2010.
Mission and Vision
Mission:
To be the preferred partner to our Sponsors in providing complete solution to product development with unique hallmarks of Quality and Innovation in the process of integrating and streamlining the development.
Vision:
To be the most respected partner in providing product development and unmet clinical research needs.
Clinical Services
• Clinical Operations • Data Management• Statistical Analysis• Quality Assurance• Regulatory Affairs• Medical Writing• Pharmacovigilance
Operational Plan
INVESTIGATOR SELECTIONPLANNING REGULATORY STATISTICAL INPUT
MEDICAL COMMUNITY MEDICAL WRITING
IN PUT
OPERATION CONTROL REPORTINGPROJECT EXECUTIONASSESSMENT
PROCESS
COST EFFECTIVE
LOW RISK
QUALITY DATA FAST RECRUITMENT BIGGER MARKET
OUT PUT
S
Y
S
T
E
M
Project Approach
SFA- Site & Study
feasibility
Analysis
PP- Project Planning
PMC- Project
Management
and Commissioning
Data ManagementSe
t Up • CRF Design
• Creation of Project specific Guidelines
• Database Set-up• Annotation• Design• Query• Programming• Validation etc.• Import/Export Set-up• Dictionary set-up(e.g.
MedDRA)• CRF Tracking Set-up• Protocol Inputs
Proc
essi
ng • Double Data entry & verification
• Query Management• Clinical data Coding• Data Import/Export• Audit trails and access
log maintenance• Project specific
Document Management• SAE** Reconciliation
Revi
ew
• Adverse events• Margin notes and data
alerts• Evaluation of medical
and scientific consistency of data
• Trend Analysis• Periodic review for
protocol adherence, data recorded and regulatory file maintenance
• Data Quality Control
Data ManagementCl
ose-
Out • 100% Quality Control of
selected patients (i.e. selected randomly)
• Soft/Hard Locking of database
• Relevant project closure documentation (Data Handling Report)
Paper Based Studies- Open Clinica, Oracle Clinical 4.6, MS-EXCESSEDC Studies-Oracle RDC, Medidata RAVE, INFORM
Statistical Analysis and ProgramingSA
P cr
eatio
n &
set
-up • Study objectives are
summarized• Study population finalized• Sample size rationale and
statistical power determination
• Description of statistical methodology
• Create and finalize• Programming processes
and directory structures• Shells of all planned
tables, listings and graphs
Stati
stica
l Ana
lysi
s • Creation and validation of analysis datasets using CDISC* standards
• Creation of integrated databases
• Creation of tables, listings and graphs
• Exploratory analysisSummary of methodologies and results
• ISS & ISE
QC/
Val
idati
on
• Programming and quality review based on written specifications
• Independent validation of all project-specific programming
• Quality review of all outputs
• Senior review
Statistical Analysis and Programing
Repo
rt G
ener
ation
• Prepare integrated clinical/statistical Reports
• Programming
• Report generation
Statistical Tool-SAS-9.2
Contd.
E-Submission
• Creation of e-submission deliverables
• CRF Annotation• SAS Transport Files• Define. PDF/ Define.xml• eCTD Guidelines• QA of deliverables• Hyper linking• ISI Toolbox, Ultralink
Pharmacovigilance
• Adverse Event Planning• SAE Reconciliation• Signal Detection• Medical Evaluation• Safety Reports• Literature Search• P2 Table
Medical Writing
• Manuscripts• Slide Kits• PostersCTR* Summary• CSR• Annual Safety Reports• Protocol• Investigator Brochure Financial Disclosure• Patient narratives• Abstracts• Informed consents• Risk profile
Medical
Writing
Transforming Customer Expectation
Hassel free regulatory approvalTime bound completion of ProjectFast Requirement Large investigator poolAllows sponsor to view real-time project development
Innovative Approach
We have conducted a Disease surveillance report (DSR) in all regions of India to ensure:
* Fast feasibility and Documentation* Investigator/Patient Database * Fast Recruitment rate* Excess of Patient Data in small cities* Physician Database
Study Design* We have high success rate in NDAC* We are having maximum Study approvals in India* Patient and Recruitment friendly study design
Patient Recruitment* Audio Visual consenting* External OPD* Physician Referral
Differentiating Factor
Transparent Service through: * EDC * Documentation Control System
Advanced Technique:* Project Management Software* Randomization
Better Risk Assessment & Management Skill Strong Regulatory Background Source Data Verification 100% Globally acceptable SOPs Policy Enforcement Presence in Germany, Denmark, Australia and South Africa
Tools
The tools used at Genelife Clinical Research are: Project Management SoftwareClinical Data Management SoftwareDocumentation Control SystemCentral Randomization Software Temperature Control System for IP
Expertise
S. No. Indication Status Regulatory Body Number of Project
1 Cancer 1Completed/ 1On going 1 AYUSH, GmbH 2
2 Gynecology 1Completed/ 1On going DCGI 2
3 Gastroenterology Completed FDA 1
4 Dermatology Completed 1 FDA, 1TGA 2
5 Male Health Completed AYUSH 2
6 Female health Completed Non-Regulated 1
7 Respiratory 1Completed/ 1On going DCGI 2
8 Liver Dysfunction Completed Non-Regulated 1
9 Ophthalmology On going DCGI 16
10 Hypertension On going DCGI 5
11 ENT On going FDA 4
12 Diabetes On Going DCGI 2
13 Orthopedics On Going DCGI 4
14 Infection On going DCGI 1
Expertise
S. No. Indication Status Regulatory Body Number of Project
1 Hemostat On going DCGI 1
2 Stent Completed TGA 1
3 Asthma On going DCGI 1
3 Diagnostics Completed Non-Regulated 1
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