Vishwanath Iyer & Ashwini Mathur
Statistical concepts for clinical research
Giriprasad Bommisetty & Manjushree
Lab CTC Grades Unveiled
Indrani Kakade
Study Set-up: The Roadmap For Effective Data Collection
Celestine Juliet Rebello
Selection and Training of Clinical Research Partners
Prathap Tharyan
Study Design: The Blueprint for success
Dr. R A Badwe
Clinical Research : End User’s Perspective
Deven Babre
Pathway to Quality Management of Study Data
Ritwik Sinha
Analysis Planning and Safety Monitoring: The Statistician as a Trialist
Bindu Narang
Medical Communications: Messaging to Internal and External customers
Murali Ganesan
Standards in analysis & reporting
Shailaja Chilappagari
Demystifying the Jargon
Manish Paliwal
Regulatory interactions: Engaging effectively for success
Ranjani Nellore
REGULATORY FILINGS IGNORANCE IS BLISS?
Vijay Srinivasan
eCTD: A farewell to paper submissions
Viraj Suvarna
Comparative Effectiveness Research From safety and effectiveness to risk‐benefit
Compiled file
ConSPIC 2011 - Day 1 Track 1
Compiled file
Workshop in Pharmacovigilance
Day 2 Track 2
Chethana Kalmady
Adaptive Bayesian dose findings
DR BALASUBRAMANIAN
Oxazolidinone for the treatment of Tuberculosis (TB)
Dr Vishwanath Iyer & Dr Ashwini Mathur
Clinical Trials Design Workshop
Raghunathan Srivastsan
Statistical Analysis for Biomarker Identification
Jyothi Subramanian
Pharmacometrics – PK/PD Modeling
K.S. Rao
Role of Toxicology Data in Drug Development
Demissie Alemayehu, Ph.D.
Meta-analysis in Risk-Benefit Evaluation
Dr Ravisekhar Kasibhatta
CLINICAL ENDPOINT STUDIES IN GENERIC DRUG DEVELOPMENT
Young Jack Lee, Ph.D.
Bridging studies: whether to bridge, how to bridge and what to bridge
Moumita Sinha, PhD
Biosimilar Development: Design and Statistical Challenges
Dr Sheetal Ingole
Regulatory Considerations in Designing of Respiratory Studies for Generic Drugs
Abhishek Mishra
Simulations in Clinical Trial Design
Dr Vidyadhar Phadke
Sample Size Re-estimation in Late Stage Trials
K.E.Sudarsan
Using PERL Regular Expression in SAS-Useful and Powerful Tool
Dhaval Mehta
Extracting tracking information for data management team from oracle clinical
Ninan M. Luke
Integrating Perl scripting with SAS
Senthilnathan Ramanathan
Overview of user Defined SAS Functions and Subroutine
Suman Kapoor
Utility Macros
Devayani and Rosemary
Box Plot and Clinical Trial Analysis
Sakthivel S, Reshma K R
A Pragmatic Tool for Clinical Trials in Analyzing Repeated Measures Categorical Data
Sasikumar S
Addition of R Programming in Clinical Domain
Swapna Kopalla
Registering and Reporting Results with Clinicaltrials.gov.in
Mahesh Babu Mayakuntla & Prasanna Kumar Nidamathy
RECIST and Programming Challenges
Gauri Khatu
Exposure to Exposure
Prabhakar Munkampalli
QT analysis: A Guide for Statistical Programmers
Sarfaraz Sayyed
Cross Validation Made Easy
Sugunesh Sivalingam
Challenges in Analyzing Laboratory Values and Measurements
Rijesh Paramal
10 Possible mistakes in Statistical programming
Tejaswni Abhyankar
Validation of Statistical Analyses in Cosmetic Trials using R
Urmi Bhatia, Aditi Kakade and Yogesh Yewale
Utility of SAS Graph Annotation
Hari Vardhan J
Graphs Made Simple using SG Procedures and GTL
NISHANTH NALAN
Visualizing data using SAS GTL (Graphics Template Language)
Abhinav Jain
Unleashing Potential of Graphs for Analysis of Adverse Events
Imran Khan
Competent SAS Programmer: Need of BPO Industry
Benazir Ibrahim
Phasing: Concept and Real Life Challenges
Vinay Mahajan and Pawan Sharma
Do We Know Enough about Drug Exposure?
Sudarshan Sareddy and Vikram Venugopal
Role of a Statistical Programmer in an Intra-patient Dose Escalation Trial
Ramkumar M.Rajendiran
Copy, Paste and Misanalysis
Abhishek Bakshi
Bag it, Tag it & Put it::Project tracking one click away!
Pankaj Bharadwaj
Tools, Technologies and Techniques in Clinical Data Standardization
Gaurav Chauhan, Arun Kumar, Pankaj Mishra
SAS Programming Tool to Create Statistical Outputs for Bioavailability and Bioequivalence studies
Pratibha Jalui
Adaptive Designs in Clinical Trials
Rajalakshmi
Randomization
Vibhavari Inamdar
Array Presentation
Ravisekhar Jayanti
Data Manipulation using SAS Arrays
Rahul Paul Chaudhary
SAS@XML Mapper Tool – An Underdog in Clinical Domain!
Dr. Arun Nanivadekar [Keynote Speaker]
Statistics in Clinical Trials – Some emerging issues
Saumil Tripathi
Bringing repeatability and automation to the data integration process for organizing, standardizing and managing clinical research data and metadata
Raj Jhaveri
Overview of SAS Education
Prof. A. P. Gore
Healthy Numbers – Historical perspective of quantitative analysis of health
Dr. Ashwini Mathur
Clinical Trials – History and Ethics
Dr. Vivek Ahuja
Advances in safety data analysis - the Journey
Dr. Tausif Ahmed
Role of PK/PD in Evidence based Medicine
Dr. Saurav Roy
Adoption of SaaS and cloud technology by pharma & CROs
Dr. Vasudeo Paralikar
Creating Evidence Base: An Example of NSDs
Dr. Sheela Godbole
Cohort studies in HIV: The Journey of Evidence for HIV in India & Registry Match Studies: HIV Database and Cancer Registry Match
Dr.B.Unnikrishnan
Systematic Reviews & Meta Analyses
Dr. Sunita R. Nair
Communicating Results in Publications: A Perspective
Dr. Piyush Agarwal
Use & presentation of evidence while launching & marketing products
Dr. Gouri Pantvaidya
How is the evidence used by a prescriber?
Dr Arun Bhatt
Current state of clinical research in India
Sanjib Basu
Introduction to Survival Analysis - Workshop slides
Pratibha Jalui & Pooja Shinde
Managing the Unspoken Customer Expectations
SURESH KUMAR KOTHAKONDA
PLAN YOUR WORK USING PROC CALENDAR
Manoj Panday
The Graph Template Language (GTL)
Ramya Kode Dhaval Naik
A Study to Identify Assessments Impacting Patient Burden
Sridhar Kantamani
Insights into Data Visual Analytics - A new Paradigm
Dr. Chirag Trivedi
Conducting clinical trials in India - efficient planning and ensuring success
Santhosh Chetpelly and Paramkusham Kishore Kumar
Execute efficiently by using call execute
Madhubhushan Eada and Satyendra Kuril
Enhancing outputs with PROC TEMPLATE
Raju Tadala
INTERVAL CENSOR DATA WITH SAS
Priyesh Sura
What, How and WHY’s Law
Jasmin Jobanputra
Sneak peek of Trial Design Model
Madhusudhan Bandi
Molecular modeling – to ease drug discovery in clinical industry
Aditi Kakade & Garima Joshi & Vidya Raja & Tamilselvi Senthilkumar
Idiosyncratic Plots to Visualize the Clinical data
Senthilkumar and Srihari
Out of Box Thinking
Renjana Prasannan and Apoorva Singh
Analysis Data Reviewer’s Guide (ADRG) – A Road Map
Ravi Gupta and Jagadish Katam
PERL REGULAR EXPRESSION IN SAS
Mustaq
Methods of Creating Define.xml and Challenges Faced
Pratibha Jalui and Reetabrata Bhattacharyya
Imputation of Missing Data through Bayesian Approach
Shilpakala Vasudevan and Padmashree Jahagirdar
Patient Reported Outcomes - PROgressive approach to clinical trials
Aditi Marate and Naseema Shaik
Analysis of Failure Times in the Presence of Competing Risks and its SAS procedures
Nandana Prabhu
Construction of Williams Square Design and Randomization in Cross Over Trails Using SAS
Chaitanya pradeep repaka
Unleashing the black box of debugging in Validation
Praveen Aleti
“D” Wise approach for “Device” trial
Sadanand Deshmukh
SAS functions – easy way to remember
Shrikrishna shroff
Importance of RAV analysis in Hepatitis-c studies
Janki Chokshi
Guidance For Evaluating Responses in Multiple Myeloma
Srinivas Devasani and Anupkumar Baheti
Deciding Clinical Trial Endpoints in Oncology Studies
ARUNA CHAKRABORTY
SDLC in Statistical Programming - A Possibility?
Pavithra and Melvin and Roshan
OVERVIEW OF PATIENT PROFILES
Dhivagaran and Sandeep
SMAC AND ITS ROLE IN CLINICAL TRIALS
Harish Kumar and K Pallayya Guptha Vura
EXCEL'ing Quality With Efficiency
Rammohan and Naveen
Creating consolidated XML by using VBA to EUDRACT/ICTRP/FDA
Apoorva Singh
Tips for Handling and Creating Special Characters in SAS
Vamsidhar Terala
Implementing multiple baselines in ADaM BDS datasets
Sandhya Yalla
TD - Trial Disease Assessments Domain in SDTM IG 3.2
Anusha Bhimavarapu & Ashok Kodali
Cross Over Trial Design:CDISC Data Structure
Anitha Cecelia
Handling correlated data using GLIMMIX procedure
Satish Bhosale & Amitava Mukhopadhyay
Monitoring Safety Signal in Clinical Trial(s)
Venkateshwarlu Y
Bootstrap - Resampling
Soumya Rout
Optimal Planning of Clinical Trials
Sarath Krishna
Challenges in Building better 'EDC System in Clinical Trials'
Thoufic Ahamed
An Activity to Track Ongoing Clinical Study Data Capturing Process Efficiently
Sakthivel Sivam
Pooling of 25 years old legacy studies data captured in different languages for DSUR preparation
Swati Kapuganti and Naveen Katarki
An observational study – as observed by a programmer
Gloria D'Souza
Efficient Data Specification creation for ADAM studies in a multi-resourcing model environment
Swarnalatha Madupu
How ‘Significant digits’ are significant in clinical trials
Puliraju Mandati
Quality adjusted survival (Q-TWiST)
Suman Kapoor
Think Twice before using Regression
Aditi Marathe
Methods of Safety Recurrence Analysis and its SAS Procedures
Ranjith Kumar & Madhu Guruvelli
PK/PD Modeling in Support of Drug Development
Sambasivarao Tedla, Sandeep Kambhampati
Significance of Periodical Submissions in Clinical Research
Sridhar Punniamurthi, Harish Chellam Narayanan
R Programming Validation for the Clinical Study Report
Amarnath Vijayarangan
EASE YOUR WORK WITH NOTEPAD++
Arwa Topiwalla
Strengthening Your Trial Arms
Nilesh Kumar Muthyala
Bridging Statistical Analysis Plan, ADaM Datasets & Metadata
Mousumi Biswas
EXPOSURE TO EXPOSURE 'AS COLLECTED'
Soujanya Konda, Padmavathi Karumuru and Amruta Pathak
Magic of Analytics in Clinical Trails
CHARAN KUMAR, SRINIVAS RAPELLY
MEDICAL MONITORING
Karuna Gawde
Usage Of Mahalanobis Distance Statistics in Clinical Data
Kalaivani Raghunathan, Egappan Rama
Dashboard for Project Management Using Excel adn R
Pratibha Jalui
Standard Macro System
Bibas Timilsina
Risk Mitigation In Clinical Trail Projects
Nishanth N
FSP Business Model
Vikas Dhongde
Electronic Submissions
Ramya Deepak, Aditya Shah
EudraCT-A new way forward for greater transparency
Satheesh Kantam,Sathish Reddy Ganga,Sarita Pasi,Aditya Kamat
Anonymization of Clinical Trial Data
PRASANTHI BONALA,VIJAYAN GOVINDHARAJAN
ADAPTIVE DESIGN CLINICAL TRIALS
Karunakar Narahari
Selection of Test Model
Manoj Pandey,Writwik Mandal
ROC Curve:Making way for correct diagnosis
Anusuiya Ghanghas
Effortless Validation:It's so simple
Rajasekhar Mudugu
Automating the code for Command Line Interface in OpenCDISC Validator
Dhananjay Thakur
SDTM Annotations-Checker and Mapper-Automated Approach
Rupali Belose, Aditya Tembe
HIV Studies:An Overview for Programmers
Narasimha Rao B
An Overview of Key Efficacy endpoints and how to attain them in Oncology Trails
ARUNA CHAKRABORTY
OPHTHALMOLOGY IN CLINICAL TRIALS
Ashwin V
OpenTLF
Neelam Yadav
Next Generation Sequencing magnifying glasses to read your DNA
Priyanka & Satish
ODS Graphics Designer - beyond point and click!
Anantha Jothi Sankaran
Presenting statistics in KM Plot in the way Clinicians & Statisticians would love to see it !!
Vishwanath Iyer, Ashwini Mathur
Statistics for non-statisticians - concepts useful for clinical research
Vivek Ahuja
Advances in safety data analysis – the journey
------
Adoption of SaaS and cloud technology by pharma and CROs
Jagannatha P.S.
Clinical Study Design: Statistical Considerations
Compiled file
ConSPIC 2011 - Day 2 Track 2
Chirag Trivedi
Adaptive-Monitoring
Krishna Asvalayan
Database Design and Optimization for Signal Detection
Smit Shanker
Life Science Market Sell
Saurabh Gupta
Next Generation Sequencing - Challenges and solutions
-------
Predictive Modelling for Commercial Usage
----
Safety Signal
Harsha Urlam
Text-Analytics-IASCT
Vishwanath Iyer(Mahesh)
Safety in clinical research
Stephen Pyke
The value of data 2014
Manish Pathak, Konark Garg
CLM Social Media
Ramanan Ezhil Arasan
Detecting safety signals
S Anand
Insights from Data
Saumyadipta Pyne
PYNE Statistical Frameworks for Big Data Analysis
Chitra Lele
Signal Detection Regulations Data Sciences Paradigm
Anish Shah, Ashish Aggarwal, Roshan Stephen, Harun Rasheed
Deep Dive into ADaM - Workshop material
Charumathy Sreeraman
Challenges in creating SDTM trial design datasets for complex study designs
Arunava Chakravartty
Adaptive designs in biopharmaceutical development
Shashidhar J Savanur, Vishwanath Iyer (Mahesh)
Statistical Applications in Clinical Trials
Prerit Pancholiya, Sameer Bamnote
Graphs made by easy using SAS & R -material
Jagannath Kota, Vinay Kumar Venishetty, Prasanna Kumar Nidamarthy, Chandrasekhar Bhupathi
PHARMACOKINETICS ANALYSIS WORKSHOP MATERIAL
Nithiya Ananthakrishnan, Sridhar Punniamurthi
Signal Detection in Pharmacovigilance
Pratibha Jalui, Amitava Mukhopadhyay
Safety Signal How far are we from detecting it
Arnab Sengupta, Rajat Nanda
Using Analytics to Monitor Patient Safety
Venkatesh Krishnamurthy, Sravan NagiReddy, SatyaVyshnavi Thondapu, Milan Bhagat
Risk Based Monitoring
Rohan Sathe
Predicting Future Course of Clinical Trials
Rajan Josephraj Paul, Swarna
Big data analysis in Clinical Trials
Manigandan Ramkumar, Kapil J Anand
Forecasting Trial Cost at Pre-clinical Development Stage
Vikas Sharma, Deepali Pilankar, Swati Rizhwani
Data Driven Approach to identify Scientific Misconduct in Clinical Operation
Padmasree Sirigireddy
Associated Person Domain
SUNIL GANESHNA
Multiple Baseline Implementation
V Vishnu BapuNaidu
Vertical ADaM a long look
Vamsidhar Terala
Biomarkers as Clinical Endpoints
Neha Srivastava
Adverse Events-Intensity behind the scenes
Prathamesh Athavale, Vikramaditya Yandapalli, Ajay Yalwar
Implementation & Applicability of PROC FCMP-Creating Dynamic Custom Functions
Shelendra Singh Pawar, Meghana Kulkarni, Shveta Natu
Overview of Reporting Adverse Eevents of Special Interest
Naveenpal Arumugam
The BRIDG MODEL- DAM for regulated clinical research
Peddiboyena Lalitha,Rathan Kumar Rangu
SDTM TRAIL DESIGN MODELS
Sagar Das
Challenges In Assignment Of EPOCH In Partial Blinded Crossover Trials
Rohith, Neelam
Can we automate human life value
Prabhatha Mateti, Marshal Chettiar, Ajay Daparthi
Pharmacokinetics -Compartmental Model and Data handling Challenges in CIDSC world
Shabbir Bookseller, Abdulkadir Lokhandvala
Basic to Advance, ODS is all you need to know
Obulpathi Naidu K
Traceability Checks For CDISC ADaM
Ranjan Routray, Lekshmanan, Shrishaila Patil
Evolution of SDTM, General Pit falls and Best practices
Prashant Suthar
SDTMiG 3.3-New Domains and Variables
Tushar Sakpal
Metadata Repository (MDR) When it Fails
Soma Sekhar.K, Thamarai Selvan.P, HUSSAIN SABIR, SAMUNDEESWARI
A Practical Approach to create Define.xml and Define
Rashmi Seta
Jumpstart- A Quick Data Review Tool
Sugunesh Sivalingam
A SAS® Macro for Computation of Exp-Adjusted Incidence & Event Rate with CI in AE Analysis
Kiruthiga
Utility to automate creation of datasets with metadata and simplify process of updating datasets
Shivaram Sharma
Robust macro for issue tracking and to check the Data and Metadata updates between data transfers
Pradeep Kiran
Baseline calculation and visit mapping in Concomitant medication
Mangala, Shilpakala
ADTTE - A Dynamic Tool To Effectively interpret clinical outcomes
Janki Chokshi
Building ADaMDataset for Oncology (Non time to event and Exposure) data the BDS way
m l n v sai krishna, m ratna sarika
can medical devices change the way we treat the patient
Dineshkumar.N
Strategies to overcome the future resourcing demands of SAS Programmers
Husayn Ahmed
Can there be an alternative to cancer clinical trials
Korak Datta
The seven year itch
Pavan Kumar Anna
Comparison of Weibull and Cox proportional hazard model for time to event data
Noirrit Kiran Chandra, Prof Sourabh Bhattacharya
Detecting miRNA expression level diff for Gingivo buccal squamous cell carcinoma patients
Nishanth N
Mindfullness
Pradeep Acharya, Thejas M S
DOSUBL AN IMPROVED VERSION_OFCALL_EXECUTE
Senthil Yuvaraja, Suresh reddy
Exploring Oncology Domains
Rajendra Desai, Ayan Das Gupta
Evaluation & regression diagnostics of covariate adjusted Cox PH model with patient-scored prognostic factors
Pavan Sagi
Features of Nanotechnology in Clinical industry
Farooq Ali, Kedar Maheshwari
Data De-identification and Anonymization - Guidelines and Implementation Challenges_
Devika Shanmugasundaram, Lakshmanan Jeyaseelan
Generalized Poisson Regression Model with an Application to Malnutrition Data
Manohar Naidu V., Praveenraj Mathivannan
The Tangled Tale - Painful process in laboratory data integration, reconciliation and review
Sreenath Kodoth
GLM with advanced SAS procedure PROC HPGENSELECT and its comparison with PROC GENMOD
Vijay Reddy
Working with define.xml V2.0 in SDTM environment
Venugopal Purini, Pradeep Acharya
Graphical tool for visualizing Liver-Tox with other patient treatment parameters –a macrowised approach
Amitkumar Kawle,Kishore kumar Paramkusham, Abhinav Kumar, Nitin Suryawanshi
Enhanced Pinnacle 21 Reports using SAS
Mahesh, Ranjan, Shoba, YellaReddy
GTL - Customizing graphs made easy
Trupti Vaidya
Identification of Stochastic Pattern in the Return Time Distribution of K-Mers in Mumps Virus Genomic Data
Manjinder Dalam
Identifying and Reviewing Outliers using Statistical methods
Vaishali Marathe, Yogesh Jagtap
Incidence Rate
Poorna devi Ch
KMplot Macro-to generate enhanced Kaplan-Meier plots
Avinash gupta, Pritam gupta
Lasagna Plot
Sreekumaran Nair
Systemic Review - Has it been a game changer in clinical research
vura k pallayya guptha
Let graphs speak using r
Anitha Cecelia
Latent class analysis using proc LCA
Devender Sandhi
Managing Textual information dynamically in a Graph using Proc Template
Priya D'silva
Forecasting the efficacy in Longitudinal studies using change points in mixed models
Shailesh Gupte
MEDICAL DEVICE - DO YOU KNOW
Ganesh L
Overview of Class III Device trials
Jairaj, Bhargav, Ramiya
Insights on QT/QTc studies in clinical trials-Evolution Elaboration and Evaluation
Pritam Gupta
Beta regression models for analyzing QOL data in Acromegaly
Priya Govindswamy
Proc GLIMMIX
Suryakant Somvanshi, Mahendra Bijarnia, Ayan Das Gupta
Sample size determination in clinical trials
Shirisha Sugavasi
Randomization schedule using Proc Plan
Chandrasekhar Bhupathi
Do we really need high sample and power for BE studies
Kumar Rajinder
SAS Grid - Simplified
Sahana Prasad
Some Statistics on Palliative care in India
Ramakrishna Battula, Paridhi Jain, Shital Pokharkar
Dose Escalation Designs
Swapna Biradar
Star charts in SAS
Yajnaseni Chakraborti
Modelling efficacy and toxicity in Oncology dose-finding studies
Amruta
Statistical Analysis of Neuroscience Data
Ashwini Shenoy
Bayesian predictive approach to interim monitoring in clinical trials
Vishal Kundan
The Uncommon Macro Debugging Techniques – A must to know for the Statistical Programmers
suman sarkar
Two stage group sequential analysis
Snehal Patange
XML And Webservices-A match made in SAS
Soorma Das
Two Stage Multi-Arm Design
Gordhan Bagri
Seamless two stage adaptive design in clinical trials
Dr.Shesh Rai
Phase II Clinical Trial Design Incorporating Toxicity Monitoring
Dr. H. V. Kulkarni
Two Sample Comparisons Involving Zero-Inflated Continuous Data - Parametric Approach and Recommendations
Tuli De
Comorbidity as prognostic factor in clinical trials in patients with hematologic indication
Meera Mohan
Importance of Randomly selected blocks in Block Randomization
Dr.Arindom Chakraborty
A Spline Enhanced Population Pharmacokinetic Ordinal longitudinal Model subject to Informative Dropout
Aditi Marathe, Garima Joshi
Covariate Selection in Model Building
Neha Pandey
Tipping point as a sensitivity analysis
Chaitali Pisal
Statistical Method for Identification of Biomarker Driven Subgroups
Debasis Dey
Securing Privacy by Minimizing Disclosure Risk in De-identified Data
Hitendra Pandey
Modeling Unstructured Covariance Matrix-When it works and when it doesn't
Abhinandan Chakraborty
Exploring the underlying distribution of PK parameters
Bristi Bose, Pankaj Tiwari
Different imputation methods use in Clinical Trials
Suresh Kumar Kothakonda
Gate Keeping Strategies in Clinical Trials
Ravinder Arakati
Different approaches for handling treatment switching for reporting in clinical studies
Surbhi Vijay, Ashutosh Mishra, Prashant Kulkarni, Shyam B Tiwari
Use of Propensity Score Matching (PSM) in Non-interventional Study
Dr.Atanu Biswas
A class of Covariate-Adjusted Response-Adaptive Allocation Designs for Multi-treatment Binary Response Trials
Ashok Kumar Singh
Analysis of Competing Risk Data with Masked Cause-of-Event
Rajan Sareen, Sonam Singh, Keerthana Palwai
Modelling and Analysis of Recurrent Event Data
Sakthivel Sivam and Renjana Prasannan
Quality control and quality assurance in clinical trial workshop - Slides
Angshuman Sarkar & Bharath Kumar
Workshop on Estimands