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  • Presentations

    Statistical concepts for clinical research

    Vishwanath Iyer & Ashwini Mathur

    Statistical concepts for clinical research

    Lab CTC Grades Unveiled

    Giriprasad Bommisetty & Manjushree

    Lab CTC Grades Unveiled

    Study Set-up: The Roadmap For Effective Data Collection

    Indrani Kakade

    Study Set-up: The Roadmap For Effective Data Collection

    Selection and Training of Clinical Research Partners

    Celestine Juliet Rebello

    Selection and Training of Clinical Research Partners

    Study Design: The Blueprint for success

    Prathap Tharyan

    Study Design: The Blueprint for success

    Clinical Research : End User’s Perspective

    Dr. R A Badwe

    Clinical Research : End User’s Perspective

    Pathway to Quality Management of Study Data

    Deven Babre

    Pathway to Quality Management of Study Data

    Analysis Planning and Safety Monitoring: The Statistician as a Trialist

    Ritwik Sinha

    Analysis Planning and Safety Monitoring: The Statistician as a Trialist

    Medical Communications: Messaging to Internal and External customers

    Bindu Narang

    Medical Communications: Messaging to Internal and External customers

    Standards in analysis & reporting

    Murali Ganesan

    Standards in analysis & reporting

    Demystifying the Jargon

    Shailaja Chilappagari

    Demystifying the Jargon

    Regulatory interactions: Engaging effectively for success

    Manish Paliwal

    Regulatory interactions: Engaging effectively for success

    REGULATORY FILINGS IGNORANCE IS BLISS?

    Ranjani Nellore

    REGULATORY FILINGS IGNORANCE IS BLISS?

    eCTD: A farewell to paper submissions

    Vijay Srinivasan

    eCTD: A farewell to paper submissions

    Comparative Effectiveness Research From safety and effectiveness to risk‐benefit

    Viraj Suvarna

    Comparative Effectiveness Research From safety and effectiveness to risk‐benefit

    ConSPIC 2011 - Day 1 Track 1

    Compiled file

    ConSPIC 2011 - Day 1 Track 1

    Workshop in Pharmacovigilance

    Compiled file

    Workshop in Pharmacovigilance

    Day 2 Track 2

    Day 2 Track 2

    Adaptive Bayesian dose findings

    Chethana Kalmady

    Adaptive Bayesian dose findings

    Oxazolidinone for the treatment of Tuberculosis (TB)

    DR BALASUBRAMANIAN

    Oxazolidinone for the treatment of Tuberculosis (TB)

    Clinical Trials Design Workshop

    Dr Vishwanath Iyer & Dr Ashwini Mathur

    Clinical Trials Design Workshop

    Statistical Analysis for Biomarker Identification

    Raghunathan Srivastsan

    Statistical Analysis for Biomarker Identification

    Pharmacometrics – PK/PD Modeling

    Jyothi Subramanian

    Pharmacometrics – PK/PD Modeling

    Role of Toxicology Data in Drug Development

    K.S. Rao

    Role of Toxicology Data in Drug Development

    Meta-analysis in Risk-Benefit Evaluation

    Demissie Alemayehu, Ph.D.

    Meta-analysis in Risk-Benefit Evaluation

    CLINICAL ENDPOINT STUDIES IN GENERIC DRUG DEVELOPMENT

    Dr Ravisekhar Kasibhatta

    CLINICAL ENDPOINT STUDIES IN GENERIC DRUG DEVELOPMENT

    Bridging studies: whether to bridge, how to bridge and what to bridge

    Young Jack Lee, Ph.D.

    Bridging studies: whether to bridge, how to bridge and what to bridge

    Biosimilar Development: Design and Statistical Challenges

    Moumita Sinha, PhD

    Biosimilar Development: Design and Statistical Challenges

    Regulatory Considerations in Designing of Respiratory Studies for Generic Drugs

    Dr Sheetal Ingole

    Regulatory Considerations in Designing of Respiratory Studies for Generic Drugs

    Simulations in Clinical Trial Design

    Abhishek Mishra

    Simulations in Clinical Trial Design

    Sample Size Re-estimation in Late Stage Trials

    Dr Vidyadhar Phadke

    Sample Size Re-estimation in Late Stage Trials

    Using PERL Regular Expression in SAS-Useful and Powerful Tool

    K.E.Sudarsan

    Using PERL Regular Expression in SAS-Useful and Powerful Tool

    Extracting tracking information for data management team from oracle clinical

    Dhaval Mehta

    Extracting tracking information for data management team from oracle clinical

    Integrating Perl scripting with SAS

    Ninan M. Luke

    Integrating Perl scripting with SAS

    Overview of user Defined SAS Functions and Subroutine

    Senthilnathan Ramanathan

    Overview of user Defined SAS Functions and Subroutine

    Utility Macros

    Suman Kapoor

    Utility Macros

    Box Plot and Clinical Trial Analysis

    Devayani and Rosemary

    Box Plot and Clinical Trial Analysis

    A Pragmatic Tool for Clinical Trials in Analyzing Repeated Measures Categorical Data

    Sakthivel S, Reshma K R

    A Pragmatic Tool for Clinical Trials in Analyzing Repeated Measures Categorical Data

    Addition of R Programming in Clinical Domain

    Sasikumar S

    Addition of R Programming in Clinical Domain

    Registering and Reporting Results with Clinicaltrials.gov.in

    Swapna Kopalla

    Registering and Reporting Results with Clinicaltrials.gov.in

    RECIST and Programming Challenges

    Mahesh Babu Mayakuntla & Prasanna Kumar Nidamathy

    RECIST and Programming Challenges

    Exposure to Exposure

    Gauri Khatu

    Exposure to Exposure

    QT analysis: A Guide for Statistical Programmers

    Prabhakar Munkampalli

    QT analysis: A Guide for Statistical Programmers

    Cross Validation Made Easy

    Sarfaraz Sayyed

    Cross Validation Made Easy

    Challenges in Analyzing Laboratory Values and Measurements

    Sugunesh Sivalingam

    Challenges in Analyzing Laboratory Values and Measurements

    10 Possible mistakes in Statistical programming

    Rijesh Paramal

    10 Possible mistakes in Statistical programming

    Validation of Statistical Analyses in Cosmetic Trials using R

    Tejaswni Abhyankar

    Validation of Statistical Analyses in Cosmetic Trials using R

    Utility of SAS Graph Annotation

    Urmi Bhatia, Aditi Kakade and Yogesh Yewale

    Utility of SAS Graph Annotation

    Graphs Made Simple using SG Procedures and GTL

    Hari Vardhan J

    Graphs Made Simple using SG Procedures and GTL

    Visualizing data using SAS GTL (Graphics Template Language)

    NISHANTH NALAN

    Visualizing data using SAS GTL (Graphics Template Language)

    Unleashing Potential of Graphs for Analysis of Adverse Events

    Abhinav Jain

    Unleashing Potential of Graphs for Analysis of Adverse Events

    Competent SAS Programmer: Need of BPO Industry

    Imran Khan

    Competent SAS Programmer: Need of BPO Industry

    Phasing: Concept and Real Life Challenges

    Benazir Ibrahim

    Phasing: Concept and Real Life Challenges

    Do We Know Enough about Drug Exposure?

    Vinay Mahajan and Pawan Sharma

    Do We Know Enough about Drug Exposure?

    Role of a Statistical Programmer in an Intra-patient Dose Escalation Trial

    Sudarshan Sareddy and Vikram Venugopal

    Role of a Statistical Programmer in an Intra-patient Dose Escalation Trial

    Copy, Paste and Misanalysis

    Ramkumar M.Rajendiran

    Copy, Paste and Misanalysis

    Bag it, Tag it & Put it::Project tracking one click away!

    Abhishek Bakshi

    Bag it, Tag it & Put it::Project tracking one click away!

    Tools, Technologies and Techniques in Clinical Data Standardization

    Pankaj Bharadwaj

    Tools, Technologies and Techniques in Clinical Data Standardization

    SAS Programming Tool to Create Statistical Outputs for Bioavailability and Bioequivalence studies

    Gaurav Chauhan, Arun Kumar, Pankaj Mishra

    SAS Programming Tool to Create Statistical Outputs for Bioavailability and Bioequivalence studies

    Adaptive Designs in Clinical Trials

    Pratibha Jalui

    Adaptive Designs in Clinical Trials

    Randomization

    Rajalakshmi

    Randomization

    Array Presentation

    Vibhavari Inamdar

    Array Presentation

    Data Manipulation using SAS Arrays

    Ravisekhar Jayanti

    Data Manipulation using SAS Arrays

    SAS@XML Mapper Tool – An Underdog in Clinical Domain!

    Rahul Paul Chaudhary

    SAS@XML Mapper Tool – An Underdog in Clinical Domain!

    Statistics in Clinical Trials – Some emerging issues

    Dr. Arun Nanivadekar [Keynote Speaker]

    Statistics in Clinical Trials – Some emerging issues

    Bringing repeatability and automation to the data integration process for organizing, standardizing and managing clinical research data and metadata

    Saumil Tripathi

    Bringing repeatability and automation to the data integration process for organizing, standardizing and managing clinical research data and metadata

    Overview of SAS Education

    Raj Jhaveri

    Overview of SAS Education

    Healthy Numbers – Historical perspective of quantitative analysis of health

    Prof. A. P. Gore

    Healthy Numbers – Historical perspective of quantitative analysis of health

    Clinical Trials – History and Ethics

    Dr. Ashwini Mathur

    Clinical Trials – History and Ethics

    Advances in safety data analysis - the Journey

    Dr. Vivek Ahuja

    Advances in safety data analysis - the Journey

    Role of PK/PD in Evidence based Medicine

    Dr. Tausif Ahmed

    Role of PK/PD in Evidence based Medicine

    Adoption of SaaS and cloud technology by pharma & CROs

    Dr. Saurav Roy

    Adoption of SaaS and cloud technology by pharma & CROs

    Creating Evidence Base: An Example of NSDs

    Dr. Vasudeo Paralikar

    Creating Evidence Base: An Example of NSDs

    Cohort studies in HIV: The Journey of Evidence for HIV in India & Registry Match Studies: HIV Database and Cancer Registry Match

    Dr. Sheela Godbole

    Cohort studies in HIV: The Journey of Evidence for HIV in India & Registry Match Studies: HIV Database and Cancer Registry Match

    Systematic Reviews & Meta Analyses

    Dr.B.Unnikrishnan

    Systematic Reviews & Meta Analyses

    Communicating Results in Publications: A Perspective

    Dr. Sunita R. Nair

    Communicating Results in Publications: A Perspective

    Use & presentation of evidence while launching & marketing products

    Dr. Piyush Agarwal

    Use & presentation of evidence while launching & marketing products

    How is the evidence used by a prescriber?

    Dr. Gouri Pantvaidya

    How is the evidence used by a prescriber?

    Current state of clinical research in India

    Dr Arun Bhatt

    Current state of clinical research in India

    Introduction to Survival Analysis - Workshop slides

    Sanjib Basu

    Introduction to Survival Analysis - Workshop slides

    Managing the Unspoken Customer Expectations

    Pratibha Jalui & Pooja Shinde

    Managing the Unspoken Customer Expectations

    PLAN YOUR WORK USING PROC CALENDAR

    SURESH KUMAR KOTHAKONDA

    PLAN YOUR WORK USING PROC CALENDAR

    The Graph Template Language (GTL)

    Manoj Panday

    The Graph Template Language (GTL)

    A Study to Identify Assessments Impacting Patient Burden

    Ramya Kode Dhaval Naik

    A Study to Identify Assessments Impacting Patient Burden

    Insights into Data Visual Analytics - A new Paradigm

    Sridhar Kantamani

    Insights into Data Visual Analytics - A new Paradigm

    Conducting clinical trials in India - efficient planning and ensuring success

    Dr. Chirag Trivedi

    Conducting clinical trials in India - efficient planning and ensuring success

    Execute efficiently by using call execute

    Santhosh Chetpelly and Paramkusham Kishore Kumar

    Execute efficiently by using call execute

    Enhancing outputs with PROC TEMPLATE

    Madhubhushan Eada and Satyendra Kuril

    Enhancing outputs with PROC TEMPLATE

    INTERVAL CENSOR DATA WITH SAS

    Raju Tadala

    INTERVAL CENSOR DATA WITH SAS

    What, How and WHY’s Law

    Priyesh Sura

    What, How and WHY’s Law

    Sneak peek of Trial Design Model

    Jasmin Jobanputra

    Sneak peek of Trial Design Model

    Molecular modeling – to ease drug discovery in clinical industry

    Madhusudhan Bandi

    Molecular modeling – to ease drug discovery in clinical industry

    Idiosyncratic Plots to Visualize the Clinical data

    Aditi Kakade & Garima Joshi & Vidya Raja & Tamilselvi Senthilkumar

    Idiosyncratic Plots to Visualize the Clinical data

    Out of Box Thinking

    Senthilkumar and Srihari

    Out of Box Thinking

    Analysis Data Reviewer’s Guide (ADRG) – A Road Map

    Renjana Prasannan and Apoorva Singh

    Analysis Data Reviewer’s Guide (ADRG) – A Road Map

    PERL REGULAR EXPRESSION IN SAS

    Ravi Gupta and Jagadish Katam

    PERL REGULAR EXPRESSION IN SAS

    Methods of Creating Define.xml and Challenges Faced

    Mustaq

    Methods of Creating Define.xml and Challenges Faced

    Imputation of Missing Data through Bayesian Approach

    Pratibha Jalui and Reetabrata Bhattacharyya

    Imputation of Missing Data through Bayesian Approach

    Patient Reported Outcomes - PROgressive approach to clinical trials

    Shilpakala Vasudevan and Padmashree Jahagirdar

    Patient Reported Outcomes - PROgressive approach to clinical trials

    Analysis of Failure Times in the Presence of Competing Risks and its SAS procedures

    Aditi Marate and Naseema Shaik

    Analysis of Failure Times in the Presence of Competing Risks and its SAS procedures

    Construction of Williams Square Design and Randomization in Cross Over Trails Using SAS

    Nandana Prabhu

    Construction of Williams Square Design and Randomization in Cross Over Trails Using SAS

    Unleashing the black box of debugging in Validation

    Chaitanya pradeep repaka

    Unleashing the black box of debugging in Validation

    “D” Wise approach for “Device” trial

    Praveen Aleti

    “D” Wise approach for “Device” trial

    SAS functions – easy way to remember

    Sadanand Deshmukh

    SAS functions – easy way to remember

    Importance of RAV analysis in Hepatitis-c studies

    Shrikrishna shroff

    Importance of RAV analysis in Hepatitis-c studies

    Guidance For Evaluating Responses in Multiple Myeloma

    Janki Chokshi

    Guidance For Evaluating Responses in Multiple Myeloma

    Deciding Clinical Trial Endpoints in Oncology Studies

    Srinivas Devasani and Anupkumar Baheti

    Deciding Clinical Trial Endpoints in Oncology Studies

    SDLC in Statistical Programming - A Possibility?

    ARUNA CHAKRABORTY

    SDLC in Statistical Programming - A Possibility?

    OVERVIEW OF PATIENT PROFILES

    Pavithra and Melvin and Roshan

    OVERVIEW OF PATIENT PROFILES

    SMAC AND ITS ROLE IN CLINICAL TRIALS

    Dhivagaran and Sandeep

    SMAC AND ITS ROLE IN CLINICAL TRIALS

    EXCEL'ing Quality With Efficiency

    Harish Kumar and K Pallayya Guptha Vura

    EXCEL'ing Quality With Efficiency

    Creating consolidated XML by using VBA to EUDRACT/ICTRP/FDA

    Rammohan and Naveen

    Creating consolidated XML by using VBA to EUDRACT/ICTRP/FDA

    Tips for Handling and Creating Special Characters in SAS

    Apoorva Singh

    Tips for Handling and Creating Special Characters in SAS

    Implementing multiple baselines in ADaM BDS datasets

    Vamsidhar Terala

    Implementing multiple baselines in ADaM BDS datasets

    TD - Trial Disease Assessments Domain in SDTM IG 3.2

    Sandhya Yalla

    TD - Trial Disease Assessments Domain in SDTM IG 3.2

    Cross Over Trial Design:CDISC Data Structure

    Anusha Bhimavarapu & Ashok Kodali

    Cross Over Trial Design:CDISC Data Structure

    Handling correlated data using GLIMMIX procedure

    Anitha Cecelia

    Handling correlated data using GLIMMIX procedure

    Monitoring Safety Signal in Clinical Trial(s)

    Satish Bhosale & Amitava Mukhopadhyay

    Monitoring Safety Signal in Clinical Trial(s)

    Bootstrap - Resampling

    Venkateshwarlu Y

    Bootstrap - Resampling

    Optimal Planning of Clinical Trials

    Soumya Rout

    Optimal Planning of Clinical Trials

    Challenges in Building better 'EDC System in Clinical Trials'

    Sarath Krishna

    Challenges in Building better 'EDC System in Clinical Trials'

    An Activity to Track Ongoing Clinical Study Data Capturing Process Efficiently

    Thoufic Ahamed

    An Activity to Track Ongoing Clinical Study Data Capturing Process Efficiently

    Pooling of 25 years old legacy studies data captured in different languages for DSUR preparation

    Sakthivel Sivam

    Pooling of 25 years old legacy studies data captured in different languages for DSUR preparation

    An observational study – as observed by a programmer

    Swati Kapuganti and Naveen Katarki

    An observational study – as observed by a programmer

    Efficient Data Specification creation for ADAM studies in a multi-resourcing model environment

    Gloria D'Souza

    Efficient Data Specification creation for ADAM studies in a multi-resourcing model environment

    How ‘Significant digits’ are significant in clinical trials

    Swarnalatha Madupu

    How ‘Significant digits’ are significant in clinical trials

    Quality adjusted survival (Q-TWiST)

    Puliraju Mandati

    Quality adjusted survival (Q-TWiST)

    Think Twice before using Regression

    Suman Kapoor

    Think Twice before using Regression

    Methods of Safety Recurrence Analysis and its SAS Procedures

    Aditi Marathe

    Methods of Safety Recurrence Analysis and its SAS Procedures

    PK/PD Modeling in Support of Drug Development

    Ranjith Kumar & Madhu Guruvelli

    PK/PD Modeling in Support of Drug Development

    Significance of Periodical Submissions in Clinical Research

    Sambasivarao Tedla, Sandeep Kambhampati

    Significance of Periodical Submissions in Clinical Research

    R Programming Validation for the Clinical Study Report

    Sridhar Punniamurthi, Harish Chellam Narayanan

    R Programming Validation for the Clinical Study Report

    EASE YOUR WORK WITH NOTEPAD++

    Amarnath Vijayarangan

    EASE YOUR WORK WITH NOTEPAD++

    Strengthening Your Trial Arms

    Arwa Topiwalla

    Strengthening Your Trial Arms

    Bridging Statistical Analysis Plan, ADaM Datasets & Metadata

    Nilesh Kumar Muthyala

    Bridging Statistical Analysis Plan, ADaM Datasets & Metadata

    EXPOSURE TO EXPOSURE 'AS COLLECTED'

    Mousumi Biswas

    EXPOSURE TO EXPOSURE 'AS COLLECTED'

    Magic of Analytics in Clinical Trails

    Soujanya Konda, Padmavathi Karumuru and Amruta Pathak

    Magic of Analytics in Clinical Trails

    MEDICAL MONITORING

    CHARAN KUMAR, SRINIVAS RAPELLY

    MEDICAL MONITORING

    Usage Of Mahalanobis Distance Statistics in Clinical Data

    Karuna Gawde

    Usage Of Mahalanobis Distance Statistics in Clinical Data

    Dashboard for Project Management Using Excel adn R

    Kalaivani Raghunathan, Egappan Rama

    Dashboard for Project Management Using Excel adn R

    Standard Macro System

    Pratibha Jalui

    Standard Macro System

    Risk Mitigation In Clinical Trail Projects

    Bibas Timilsina

    Risk Mitigation In Clinical Trail Projects

    FSP Business Model

    Nishanth N

    FSP Business Model

    Electronic Submissions

    Vikas Dhongde

    Electronic Submissions

    EudraCT-A new way forward for greater transparency

    Ramya Deepak, Aditya Shah

    EudraCT-A new way forward for greater transparency

    Anonymization of Clinical Trial Data

    Satheesh Kantam,Sathish Reddy Ganga,Sarita Pasi,Aditya Kamat

    Anonymization of Clinical Trial Data

    ADAPTIVE DESIGN CLINICAL TRIALS

    PRASANTHI BONALA,VIJAYAN GOVINDHARAJAN

    ADAPTIVE DESIGN CLINICAL TRIALS

    Selection of Test Model

    Karunakar Narahari

    Selection of Test Model

    ROC Curve:Making way for correct diagnosis

    Manoj Pandey,Writwik Mandal

    ROC Curve:Making way for correct diagnosis

    Effortless Validation:It's so simple

    Anusuiya Ghanghas

    Effortless Validation:It's so simple

    Automating the code for Command Line Interface in OpenCDISC Validator

    Rajasekhar Mudugu

    Automating the code for Command Line Interface in OpenCDISC Validator

    SDTM Annotations-Checker and Mapper-Automated Approach

    Dhananjay Thakur

    SDTM Annotations-Checker and Mapper-Automated Approach

    HIV Studies:An Overview for Programmers

    Rupali Belose, Aditya Tembe

    HIV Studies:An Overview for Programmers

    An Overview of Key Efficacy endpoints and how to attain them in Oncology Trails

    Narasimha Rao B

    An Overview of Key Efficacy endpoints and how to attain them in Oncology Trails

    OPHTHALMOLOGY IN CLINICAL TRIALS

    ARUNA CHAKRABORTY

    OPHTHALMOLOGY IN CLINICAL TRIALS

    OpenTLF

    Ashwin V

    OpenTLF

    Next Generation Sequencing magnifying glasses to read your DNA

    Neelam Yadav

    Next Generation Sequencing magnifying glasses to read your DNA

    ODS Graphics Designer - beyond point and click!

    Priyanka & Satish

    ODS Graphics Designer - beyond point and click!

    Presenting statistics in KM Plot in the way Clinicians & Statisticians would love to see it !!

    Anantha Jothi Sankaran

    Presenting statistics in KM Plot in the way Clinicians & Statisticians would love to see it !!

    Statistics for non-statisticians - concepts useful for clinical research

    Vishwanath Iyer, Ashwini Mathur

    Statistics for non-statisticians - concepts useful for clinical research

    Advances in safety data analysis – the journey

    Vivek Ahuja

    Advances in safety data analysis – the journey

    Adoption of SaaS and cloud technology by pharma and CROs

    ------

    Adoption of SaaS and cloud technology by pharma and CROs

    Clinical Study Design: Statistical Considerations

    Jagannatha P.S.

    Clinical Study Design: Statistical Considerations

    ConSPIC 2011 - Day 2 Track 2

    Compiled file

    ConSPIC 2011 - Day 2 Track 2

    Adaptive-Monitoring

    Chirag Trivedi

    Adaptive-Monitoring

    Database Design and Optimization for Signal Detection

    Krishna Asvalayan

    Database Design and Optimization for Signal Detection

    Life Science Market Sell

    Smit Shanker

    Life Science Market Sell

    Next Generation Sequencing - Challenges and solutions

    Saurabh Gupta

    Next Generation Sequencing - Challenges and solutions

    Predictive Modelling for Commercial Usage

    -------

    Predictive Modelling for Commercial Usage

    Safety Signal

    ----

    Safety Signal

    Text-Analytics-IASCT

    Harsha Urlam

    Text-Analytics-IASCT

    Safety in clinical research

    Vishwanath Iyer(Mahesh)

    Safety in clinical research

    The value of data 2014

    Stephen Pyke

    The value of data 2014

    CLM Social Media

    Manish Pathak, Konark Garg

    CLM Social Media

    Detecting safety signals

    Ramanan Ezhil Arasan

    Detecting safety signals

    Insights from Data

    S Anand

    Insights from Data

    PYNE Statistical Frameworks for Big Data Analysis

    Saumyadipta Pyne

    PYNE Statistical Frameworks for Big Data Analysis

    Signal Detection Regulations Data Sciences Paradigm

    Chitra Lele

    Signal Detection Regulations Data Sciences Paradigm

    Deep Dive into ADaM - Workshop material

    Anish Shah, Ashish Aggarwal, Roshan Stephen, Harun Rasheed

    Deep Dive into ADaM - Workshop material

    Challenges in creating SDTM trial design datasets for complex study designs

    Charumathy Sreeraman

    Challenges in creating SDTM trial design datasets for complex study designs

    Adaptive designs in biopharmaceutical development

    Arunava Chakravartty

    Adaptive designs in biopharmaceutical development

    Statistical Applications in Clinical Trials

    Shashidhar J Savanur, Vishwanath Iyer (Mahesh)

    Statistical Applications in Clinical Trials

    Graphs made by easy using SAS & R -material

    Prerit Pancholiya, Sameer Bamnote

    Graphs made by easy using SAS & R -material

    PHARMACOKINETICS ANALYSIS WORKSHOP MATERIAL

    Jagannath Kota, Vinay Kumar Venishetty, Prasanna Kumar Nidamarthy, Chandrasekhar Bhupathi

    PHARMACOKINETICS ANALYSIS WORKSHOP MATERIAL

    Signal Detection in Pharmacovigilance

    Nithiya Ananthakrishnan, Sridhar Punniamurthi

    Signal Detection in Pharmacovigilance

    Safety Signal How far are we from detecting it

    Pratibha Jalui, Amitava Mukhopadhyay

    Safety Signal How far are we from detecting it

    Using Analytics to Monitor Patient Safety

    Arnab Sengupta, Rajat Nanda

    Using Analytics to Monitor Patient Safety

    Risk Based Monitoring

    Venkatesh Krishnamurthy, Sravan NagiReddy, SatyaVyshnavi Thondapu, Milan Bhagat

    Risk Based Monitoring

    Predicting Future Course of Clinical Trials

    Rohan Sathe

    Predicting Future Course of Clinical Trials

    Big data analysis in Clinical Trials

    Rajan Josephraj Paul, Swarna

    Big data analysis in Clinical Trials

    Forecasting Trial Cost at Pre-clinical Development Stage

    Manigandan Ramkumar, Kapil J Anand

    Forecasting Trial Cost at Pre-clinical Development Stage

    Data Driven Approach to identify Scientific Misconduct in Clinical Operation

    Vikas Sharma, Deepali Pilankar, Swati Rizhwani

    Data Driven Approach to identify Scientific Misconduct in Clinical Operation

    Associated Person Domain

    Padmasree Sirigireddy

    Associated Person Domain

    Multiple Baseline Implementation

    SUNIL GANESHNA

    Multiple Baseline Implementation

    Vertical ADaM a long look

    V Vishnu BapuNaidu

    Vertical ADaM a long look

    Biomarkers as Clinical Endpoints

    Vamsidhar Terala

    Biomarkers as Clinical Endpoints

    Adverse Events-Intensity behind the scenes

    Neha Srivastava

    Adverse Events-Intensity behind the scenes

    Implementation & Applicability of PROC FCMP-Creating Dynamic Custom Functions

    Prathamesh Athavale, Vikramaditya Yandapalli, Ajay Yalwar

    Implementation & Applicability of PROC FCMP-Creating Dynamic Custom Functions

    Overview of Reporting Adverse Eevents of Special Interest

    Shelendra Singh Pawar, Meghana Kulkarni, Shveta Natu

    Overview of Reporting Adverse Eevents of Special Interest

    The BRIDG MODEL- DAM for regulated clinical research

    Naveenpal Arumugam

    The BRIDG MODEL- DAM for regulated clinical research

    SDTM TRAIL DESIGN MODELS

    Peddiboyena Lalitha,Rathan Kumar Rangu

    SDTM TRAIL DESIGN MODELS

    Challenges In Assignment Of EPOCH In Partial Blinded Crossover Trials

    Sagar Das

    Challenges In Assignment Of EPOCH In Partial Blinded Crossover Trials

    Can we automate human life value

    Rohith, Neelam

    Can we automate human life value

    Pharmacokinetics -Compartmental Model and Data handling Challenges in CIDSC world

    Prabhatha Mateti, Marshal Chettiar, Ajay Daparthi

    Pharmacokinetics -Compartmental Model and Data handling Challenges in CIDSC world

    Basic to Advance, ODS is all you need to know

    Shabbir Bookseller, Abdulkadir Lokhandvala

    Basic to Advance, ODS is all you need to know

    Traceability Checks For CDISC ADaM

    Obulpathi Naidu K

    Traceability Checks For CDISC ADaM

    Evolution of SDTM, General Pit falls and Best practices

    Ranjan Routray, Lekshmanan, Shrishaila Patil

    Evolution of SDTM, General Pit falls and Best practices

    SDTMiG 3.3-New Domains and Variables

    Prashant Suthar

    SDTMiG 3.3-New Domains and Variables

    Metadata Repository (MDR) When it Fails

    Tushar Sakpal

    Metadata Repository (MDR) When it Fails

    A Practical Approach to create Define.xml and Define

    Soma Sekhar.K, Thamarai Selvan.P, HUSSAIN SABIR, SAMUNDEESWARI

    A Practical Approach to create Define.xml and Define

    Jumpstart- A Quick Data Review Tool

    Rashmi Seta

    Jumpstart- A Quick Data Review Tool

    A SAS® Macro for Computation of Exp-Adjusted Incidence & Event Rate with CI in AE Analysis

    Sugunesh Sivalingam

    A SAS® Macro for Computation of Exp-Adjusted Incidence & Event Rate with CI in AE Analysis

    Utility to automate creation of datasets with metadata and simplify process of updating datasets

    Kiruthiga

    Utility to automate creation of datasets with metadata and simplify process of updating datasets

    Robust macro for issue tracking and to check the Data and Metadata updates between data transfers

    Shivaram Sharma

    Robust macro for issue tracking and to check the Data and Metadata updates between data transfers

    Baseline calculation and visit mapping in Concomitant medication

    Pradeep Kiran

    Baseline calculation and visit mapping in Concomitant medication

    ADTTE - A Dynamic Tool To Effectively interpret clinical outcomes

    Mangala, Shilpakala

    ADTTE - A Dynamic Tool To Effectively interpret clinical outcomes

    Building ADaMDataset for Oncology (Non time to event and Exposure) data the BDS way

    Janki Chokshi

    Building ADaMDataset for Oncology (Non time to event and Exposure) data the BDS way

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    m l n v sai krishna, m ratna sarika

    can medical devices change the way we treat the patient

    Strategies to overcome the future resourcing demands of SAS Programmers

    Dineshkumar.N

    Strategies to overcome the future resourcing demands of SAS Programmers

    Can there be an alternative to cancer clinical trials

    Husayn Ahmed

    Can there be an alternative to cancer clinical trials

    The seven year itch

    Korak Datta

    The seven year itch

    Comparison of Weibull and Cox proportional hazard model for time to event data

    Pavan Kumar Anna

    Comparison of Weibull and Cox proportional hazard model for time to event data

    Detecting miRNA expression level diff for Gingivo buccal squamous cell carcinoma patients

    Noirrit Kiran Chandra, Prof Sourabh Bhattacharya

    Detecting miRNA expression level diff for Gingivo buccal squamous cell carcinoma patients

    Mindfullness

    Nishanth N

    Mindfullness

    DOSUBL AN IMPROVED VERSION_OFCALL_EXECUTE

    Pradeep Acharya, Thejas M S

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    Exploring Oncology Domains

    Senthil Yuvaraja, Suresh reddy

    Exploring Oncology Domains

    Evaluation & regression diagnostics of covariate adjusted Cox PH model with patient-scored prognostic factors

    Rajendra Desai, Ayan Das Gupta

    Evaluation & regression diagnostics of covariate adjusted Cox PH model with patient-scored prognostic factors

    Features of Nanotechnology in Clinical industry

    Pavan Sagi

    Features of Nanotechnology in Clinical industry

    Data De-identification and Anonymization - Guidelines and Implementation Challenges_

    Farooq Ali, Kedar Maheshwari

    Data De-identification and Anonymization - Guidelines and Implementation Challenges_

    Generalized Poisson Regression Model with an Application to Malnutrition Data

    Devika Shanmugasundaram, Lakshmanan Jeyaseelan

    Generalized Poisson Regression Model with an Application to Malnutrition Data

    The Tangled Tale - Painful process in laboratory data integration, reconciliation and review

    Manohar Naidu V., Praveenraj Mathivannan

    The Tangled Tale - Painful process in laboratory data integration, reconciliation and review

    GLM with advanced SAS procedure PROC HPGENSELECT and its comparison with PROC GENMOD

    Sreenath Kodoth

    GLM with advanced SAS procedure PROC HPGENSELECT and its comparison with PROC GENMOD

    Working with define.xml V2.0 in SDTM environment

    Vijay Reddy

    Working with define.xml V2.0 in SDTM environment

    Graphical tool for visualizing Liver-Tox with other patient treatment parameters –a macrowised approach

    Venugopal Purini, Pradeep Acharya

    Graphical tool for visualizing Liver-Tox with other patient treatment parameters –a macrowised approach

    Enhanced Pinnacle 21 Reports using SAS

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    Enhanced Pinnacle 21 Reports using SAS

    GTL - Customizing graphs made easy

    Mahesh, Ranjan, Shoba, YellaReddy

    GTL - Customizing graphs made easy

    Identification of Stochastic Pattern in the Return Time Distribution of K-Mers in Mumps Virus Genomic Data

    Trupti Vaidya

    Identification of Stochastic Pattern in the Return Time Distribution of K-Mers in Mumps Virus Genomic Data

    Identifying and Reviewing Outliers using Statistical methods

    Manjinder Dalam

    Identifying and Reviewing Outliers using Statistical methods

    Incidence Rate

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    Incidence Rate

    KMplot Macro-to generate enhanced Kaplan-Meier plots

    Poorna devi Ch

    KMplot Macro-to generate enhanced Kaplan-Meier plots

    Lasagna Plot

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    Lasagna Plot

    Systemic Review - Has it been a game changer in clinical research

    Sreekumaran Nair

    Systemic Review - Has it been a game changer in clinical research

    Let graphs speak using r

    vura k pallayya guptha

    Let graphs speak using r

    Latent class analysis using proc LCA

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    Managing Textual information dynamically in a Graph using Proc Template

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    Managing Textual information dynamically in a Graph using Proc Template

    Forecasting the efficacy in Longitudinal studies using change points in mixed models

    Priya D'silva

    Forecasting the efficacy in Longitudinal studies using change points in mixed models

    MEDICAL DEVICE - DO YOU KNOW

    Shailesh Gupte

    MEDICAL DEVICE - DO YOU KNOW

    Overview of Class III Device trials

    Ganesh L

    Overview of Class III Device trials

    Insights on QT/QTc studies in clinical trials-Evolution Elaboration and Evaluation

    Jairaj, Bhargav, Ramiya

    Insights on QT/QTc studies in clinical trials-Evolution Elaboration and Evaluation

    Beta regression models for analyzing QOL data in Acromegaly

    Pritam Gupta

    Beta regression models for analyzing QOL data in Acromegaly

    Proc GLIMMIX

    Priya Govindswamy

    Proc GLIMMIX

    Sample size determination in clinical trials

    Suryakant Somvanshi, Mahendra Bijarnia, Ayan Das Gupta

    Sample size determination in clinical trials

    Randomization schedule using Proc Plan

    Shirisha Sugavasi

    Randomization schedule using Proc Plan

    Do we really need high sample and power for BE studies

    Chandrasekhar Bhupathi

    Do we really need high sample and power for BE studies

    SAS Grid - Simplified

    Kumar Rajinder

    SAS Grid - Simplified

    Some Statistics on Palliative care in India

    Sahana Prasad

    Some Statistics on Palliative care in India

    Dose Escalation Designs

    Ramakrishna Battula, Paridhi Jain, Shital Pokharkar

    Dose Escalation Designs

    Star charts in SAS

    Swapna Biradar

    Star charts in SAS

    Modelling efficacy and toxicity in Oncology dose-finding studies

    Yajnaseni Chakraborti

    Modelling efficacy and toxicity in Oncology dose-finding studies

    Statistical Analysis of Neuroscience Data

    Amruta

    Statistical Analysis of Neuroscience Data

    Bayesian predictive approach to interim monitoring in clinical trials

    Ashwini Shenoy

    Bayesian predictive approach to interim monitoring in clinical trials

    The Uncommon Macro Debugging Techniques – A must to know for the Statistical Programmers

    Vishal Kundan

    The Uncommon Macro Debugging Techniques – A must to know for the Statistical Programmers

    Two stage group sequential analysis

    suman sarkar

    Two stage group sequential analysis

    XML And Webservices-A match made in SAS

    Snehal Patange

    XML And Webservices-A match made in SAS

    Two Stage Multi-Arm Design

    Soorma Das

    Two Stage Multi-Arm Design

    Seamless two stage adaptive design in clinical trials

    Gordhan Bagri

    Seamless two stage adaptive design in clinical trials

    Phase II Clinical Trial Design Incorporating Toxicity Monitoring

    Dr.Shesh Rai

    Phase II Clinical Trial Design Incorporating Toxicity Monitoring

    Two Sample Comparisons Involving Zero-Inflated Continuous Data - Parametric Approach and Recommendations

    Dr. H. V. Kulkarni

    Two Sample Comparisons Involving Zero-Inflated Continuous Data - Parametric Approach and Recommendations

    Comorbidity as prognostic factor in clinical trials in patients with hematologic indication

    Tuli De

    Comorbidity as prognostic factor in clinical trials in patients with hematologic indication

    Importance of Randomly selected blocks in Block Randomization

    Meera Mohan

    Importance of Randomly selected blocks in Block Randomization

    A Spline Enhanced Population Pharmacokinetic Ordinal longitudinal Model subject to Informative Dropout

    Dr.Arindom Chakraborty

    A Spline Enhanced Population Pharmacokinetic Ordinal longitudinal Model subject to Informative Dropout

    Covariate Selection in Model Building

    Aditi Marathe, Garima Joshi

    Covariate Selection in Model Building

    Tipping point as a sensitivity analysis

    Neha Pandey

    Tipping point as a sensitivity analysis

    Statistical Method for Identification of Biomarker Driven Subgroups

    Chaitali Pisal

    Statistical Method for Identification of Biomarker Driven Subgroups

    Securing Privacy by Minimizing Disclosure Risk in De-identified Data

    Debasis Dey

    Securing Privacy by Minimizing Disclosure Risk in De-identified Data

    Modeling Unstructured Covariance Matrix-When it works and when it doesn't

    Hitendra Pandey

    Modeling Unstructured Covariance Matrix-When it works and when it doesn't

    Exploring the underlying distribution of PK parameters

    Abhinandan Chakraborty

    Exploring the underlying distribution of PK parameters

    Different imputation methods use in Clinical Trials

    Bristi Bose, Pankaj Tiwari

    Different imputation methods use in Clinical Trials

    Gate Keeping Strategies in Clinical Trials

    Suresh Kumar Kothakonda

    Gate Keeping Strategies in Clinical Trials

    Different approaches for handling treatment switching for reporting in clinical studies

    Ravinder Arakati

    Different approaches for handling treatment switching for reporting in clinical studies

    Use of Propensity Score Matching (PSM) in Non-interventional Study

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    Use of Propensity Score Matching (PSM) in Non-interventional Study

    A class of Covariate-Adjusted Response-Adaptive Allocation Designs for Multi-treatment Binary Response Trials

    Dr.Atanu Biswas

    A class of Covariate-Adjusted Response-Adaptive Allocation Designs for Multi-treatment Binary Response Trials

    Analysis of Competing Risk Data with Masked Cause-of-Event

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    Analysis of Competing Risk Data with Masked Cause-of-Event

    Modelling and Analysis of Recurrent Event Data

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    Modelling and Analysis of Recurrent Event Data

    Quality control and quality assurance in clinical trial workshop - Slides

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    Quality control and quality assurance in clinical trial workshop - Slides