Synergizing global best practices in the CRO industry

Transcription

1 Synergizing global best practices in the CRO industry

2 KREARA - India Established on April 24 th 2004 Contract Research Services to Pharmaceutical companies Clinical Data management and Biometrics Interactive web response systems Safety and Efficacy Analysis for Clinical trials Quality of Life and Interim analysis Patient Diaries and Compliance Sample Size Calculations Randomization Schedules Statistical Analysis Plans SAS Programming Software Development & Quality Control Market Access Services Patient Reported Outcome Research Post Marketing Surveillance

3 Our Services Clinical Data Management Biostatistics/SAS Programming Medical Writing Medical Coding Training Project/Study Management Clinical Informatics Compliance and Validation Software Development and testing Pharmacokinetic analysis Health Economics CDISC/HL7

4 Advantages Reduced Costs Adequate processes in place Flexible working models Adequate supply of resources Onsite Project Management if required Experienced Team Specialized tools and methodologies

5 Location under consideration KREARA Trivandrum India Located in the southern tip of India, Technopark is a technology park in Trivandrum, Kerala. The park is dedicated to hosting technological and research establishments. It is the first and largest technology park in India. Spread over nearly 300 acres with 4 million sq. ft. of built-up space available currently, Technopark hosts over 245 IT and ITES companies employing over 32,000 IT professionals, including five PCMM level 5 company, 6 CMMI level 5 and four CMM Level 3 and over 20 ISO 9001 certified companies.

6 Important Metrics COST Continuous tracking of costs against actual hours using monthly reports from the time tracker Significant cost deviations will be assessed early on during the life cycle and sponsor will be intimated Rigorous streamlined QC Process QUALITY Separate metrics for DM and SAS programming based on our onsite offshore experience Reports that continuously monitor the metrics and further causal analysis All the hours tracked against the project will be recorded in a time tracker TIME All the deliverables will be started off with a specific deadline and any slippage will be further analyzed Any time related risks will be reported to the sponsor immediately

7 Team SAS Certified Programmers MS in Statistics or Biostatistics Averaging 3 years of experience Experience across multiple therapeutic areas MS/PhD in Statistics or Biostatistics Experience with statistical analysis plans and templates Study Design and Sample size calculations Power analysis MS/PhD in Statistics or CS 5+ years Experience with statistical safety and efficacy analysis PMP Certified SAS Programmers Statisticians Project Managers BS Life sciences graduates 1+ years experience in clinical data entry Trained in ICH/GCP and CFR PART 11 guidelines MS in Computer Science 5+ years Experience Clinical Data management Experience with standard and custom made data management applications Database design Bachelors in Medicine or life sciences Experience with Clinical Study Reports in various therapeutic areas Trained in ICH E3 Data Entry Operators Data Managers Medical Writers

8 Standard Operating Procedures General Change Management Closing & Archival Core QC Data Backup and Recovery Disaster Recovery and Management Document Filing General Documentation Guidelines Information Transfer Project Enquiry Project Infrastructure Setup Protocol Writing Quality Assurance Security System Administrator Training Version Control Data Management Blind Review CRF Design CRF Manual CRF Receipt and Distribution Data Cleaning and Validation Data Entry Application Data Entry Data Management Plan Database Lock Medical Coding Raw Data Listing SDTM Project Management Deliverables and WBS Project Initiation Project Plan Quality Plan Status Meeting and Reporting

9 Standard Operating Procedures Statistics CSR Interim Analysis Randomization Sample Size Calculation SAP Statistical Analysis Statistical Report STL Shell Generation SAS Programming Analysis Datasets Dry Run SAS Dataset Generation SAS QC SAS Qualification TFL System Administration Computer System Validation.

10 Tools and Methodologies SOPANAM A tool that was developed in house to track the SAS programming efforts for a certain project. The tool is CFR PART 11 compliant and was developed in Visual Studio.NET Time Tracker A tool developed in house to keep an exact log of the project activities that are being undertaken. This tool will help us fine tune our bidding process and also improve up on our processes Prebuilt SAS Macros These macros help us deliver the tables and listings with in a very short time span, once the analysis datasets are ready. These macros have been time tested and validated. Standard Quote Template To provide extreme transparency into our bidding process, we have built a template which will accept the various trial parameters as inputs and breakdown the costs into the most possible detail.

11 Working Models FTE Full time equivalent where in a resource as per the sponsor requirement will be working offshore and the billing will be based on the number of resources assigned Fixed Bid Based on the estimated time and material, a fixed bid will be provided to the client based on certain assumptions. Any change in the assumptions will eventually result in an amendment of costs Offshore Data Center For pharmaceutical companies and CROs who would like to establish an offshore data management and biostatistics centre, Kreara provides a Build Operate and Transfer model to set up the same.

12 FTE Model with Data Protection C L I E N T SAS SERVER VPN DATABASE KREARA

13 Kreara Secure Network

14 Overview SAS Training Program Chapter I - Overview of SAS Data Management Programming Features Analysis Reporting Chapter-2 Overview of creation of SAS dataset Chapter-3 Starting with Raw data: Basics Chapter-4 Starting with Raw data: Advanced Chapter-5 Reading data from a SAS dataset Chapter-6 Reading data from an external file or other database Chapter-7 Producing list reports Chapter-8 Programming with Character variables Chapter-9 Programming with Numeric variables Chapter-10 Programming with SAS dates Chapter-11 Combining SAS datasets Chapter-12 Statements Chapter-13 Performing Conditional Processing Chapter-14 Performing Iterative Processing Chapter-15 Working with grouped data Chapter-16 Log and debugging errors Chapter-17 Modification of the SAS data set Chapter-18 Proc Sql Chapter-19 Arrays Chapter-20 Procedures Chapter-21 Gplot procedure Chapter-22 G Charts and Greply Procedures Chapter-23 Report Chapter-24 ODS output Chapter-25 SAS Macros Chapter-26 SAS Files

15 CDM & Biostatistics Case Studies Migrating legacy data that was gathered over 10 years for 5 different studies which formed part of one big oncology project 5 months duration Created the SDTM datasets for each of these studies and made them ready for ISS submission Data Management Services using an EDC system along with TFL generation for a Phase II Dermatology study that was conducted in Japan 12 months duration Use of Datatrak as the EDC system considerably improved the data management of the entire study. Site training was provided by Kreara. TFLs were provided with in 2 weeks after the DB lock End to End Data Management and Statistical Services for a Phase III Respiratory study. Study had three arms and 180patients 14 months duration Tasks involved all the CDM and bio-statistical activities like randomisation, CRF design, SAP preparation, Data Entry, Data Cleaning, SAS Programming and CSR development. SDTM DM & SAS Programming End to End

16 Inherent Risks Is my data secure Is it backed up Is there a disaster recovery plan Is the software and hardware state of the art Slippage of time, cost and quality Frequently arise with the breakdown in the transfer of work processes Service provider lacks understanding about the clients requirements Deliberate opportunistic behavior by service providers Providers who cut corners by understaffing Asymmetric Dependence Infrastructural Risks Operational Risks Strategic Risks Set the minimum expectation before initiating the project Person to Person comparison never works (e.g. An FTE in India will cost 40% less) Onsite coordination efforts will be on the higher side during the first six months of Cost operation Reduction Expectations % attrition is the industry standard Should be worried about the attrition of the key personnel which must be maintained as a key metric Train, Legally Bind and Retain Policy Employee Turnover Need an ongoing training plan and supply of statistics, biostatistics and computer science graduates Should have experienced persons in the state which should be available for lateral recruitment Availability of Resources

17 In a nutshell Cost Effectiveness Quality Consciousness We offer Timeliness Audit Readiness