Hi Guest Sign In

  • Webinar- MCP-Mod

    Material Coming Soon

    More presentations from IASCT

    More
    Regulatory Interactions: Engaging Effect...

    Medical Device - Do You Know

    Beta Regression Models For Analyzing Qol...

    Oxazolidinone For The Treatment Of Tuber...

    Adaptive Designs In Clinical Trials

    Importance Of Rav Analysis In Hepatitis-...

    Vertical Adam A Long Look

    Adaptive Bayesian Dose Findings

    Study Designs In Oncology And Programmin...

    Statistical Concepts For Clinical Resear...

    An Overview Of Key Efficacy Endpoints An...

    Significance Of Periodical Submissions I...

    Day 2 Track 2

    Two Stage Multi-arm Design

    Workshop In Pharmacovigilance

    Seamless Two Stage Adaptive Design In Cl...

    Optimal Planning Of Clinical Trials

    Incidence Rate

    Sample Size Determination In Clinical Tr...

    Sas Programming Tool To Create Statistic...

    Recent Events

      • Nov

        20

      • Data Science at work: Stories from our consulting practice - An IASCT Social Event

        The biopharmaceutical and healthcare industries now collect more data than ever before due to advances in the variety of information sources combined with the ability to store vast quantities of diverse data, but how do we make sense of it all? Sophisticated computational techniques have been developed to analyze data, but unlocking its full value requires gaining deep insights into the right questions. This talk will present a few case studies from the speaker's consulting practice and expertise in experimental design and data analytics, illustrating how answering the right questions matters most, and that statistical modeling techniques remain at the heart of data science. This session is the first Social Event being organized by IASCT and hosted by Cytel Statistical Software & Services Private Limited. This fast paced 45 minute talk session followed by a time of interaction is a great opportunity to network and connect with industry experts.

        Nov 20 2019

      • See Content

      • Nov

        13

      • Conference for Statistics and Programming in Clinical Research(ConSPIC)

        The 10th edition of ConSPIC will be held in Goa in November. Visit the ConSPIC 2019 page for more information.

        Nov 13-15 2019 | Radisson Blu Resort, Cavelossim Beach, Goa, India

      • See Content

      • Oct

        18

      • Deep dive into Regulatory submissions – role of Programmer / Statistician

        Regulatory submissions are very important milestones for pharmaceutical organizations/sponsors post completion of analysis and reporting of any clinical trial that documents the safety and efficacy data of their new innovative medicinal products. In order to accelerate and shorten the time from lab to market and bring clinical benefits to patients faster, while ensuring patient safety and optimizing research investments, we require quality regulatory submissions. This would also speed up regulatory agencies’ review, evaluation and approval of new products. eCTD (electronic Common Technical Document) is a standard required format to submit all the clinical research and development data of a new investigational product to the Health Authorities. In addition to individual clinical study reports, sponsors require to pool safety and efficacy data from individual clinical studies, prepare, and submit Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) reports into CTD for product benefit-risk evaluation. After a regulatory submission, there are usually Health Authority Questions (HAQs) on data and sponsors may need to explore/investigate individual or pooled study data, reports and provide responses quickly back to the HA. After review of submitted dossier, the HA may decide to further evaluate the product through Advisory Committee (AdCom) meeting discussions before their decision on product approval. Sponsors may have to prepare additional exploratory analyses for any potential questions from the AdCom meetings. For any regulatory submission, statistical programmers and statisticians play key roles in the preparation of the submission deliverables and also planning and generating ISS/ISE reports, responding to HA questions and performing exploratory analyses for AdCom meetings. This workshop will aim to discuss various statistical activities required for regulatory submissions in multiple therapeutic/disease areas with case studies/examples, including roles and responsibilities of statisticians and statistical programmers. This will also delve into common challenges in planning and generating the reports including electronic submission requirement per CDISC compliance.

        Oct 18 2019

      • See Content

      • Oct

        15

      • PSI Scientific Committee Webinar: Statistical Challenges in Analytical Comparability and Biosimilarity Assessment

        This webinar will discuss statistical requirements for the assessment of analytical comparability and similarity assessments, for example between biosimilars and reference products or before and after manufacturing changes. This topic has been the subject of a recent EMA reflection paper and an EFSPI working group. New strategies are proposed as an alternative to mean comparisons and include the assessment of ranges, inferential approaches or the use of Bayesian methods.

        Oct 15 2019

      • See Content

    IASCT ECHOES Issues

    • IASCT ECHOES January 2015 Issue

      Issue available

      Read more

    Useful links / Resources

    IASCT Twitter Feed