Strategic consulting services in India - Genpro Research - PowerPoint PPT Presentation

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Strategic consulting services in India - Genpro Research

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Genpro provides strategic consulting services in regulatory submissions, data submissions and early stage studies.Our expert pool of statisticians, regulatory experts and Submission specialists will help our clients at every stage of the trial. We will support you through the FDA interactions and data monitoring committee support. We have some of the best talent when it comes to adaptive and bayesian design. – PowerPoint PPT presentation

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Title: Strategic consulting services in India - Genpro Research


1
Strategic consulting services
  • Genpro provides strategic consulting services in
    regulatory submissions, data submissions and
    early stage studies.Our expert pool of
    statisticians, regulatory experts and Submission
    specialists will help our clients at every stage
    of the trial. We will support you through the FDA
    interactions and data monitoring committee
    support. We have some of the best talent when it
    comes to adaptive and bayesian design.

2
  • Strategic Consulting Services
  • STRATEGIC CONSULTING
  • De-risking portfolios, accelerating timelines,
    and increasing the probability of success. We
    believe that expert statistical input has
    the power to shape the future of clinical
    development de-risking portfolios, accelerating
    timelines, and increasing the probability of
    success.
  • REGULATORY
  • We offer comprehensive regulatory advice to
    assist our clients in achieving success in the
    product approval process and post approval
    regulatory compliance. Some of our services
    include, Strategic planning and overall
    regulatory process management, Interactions with
    regulatory agencies and Electronic common
    technical document (eCTD) preparation.
  • BIOSTATISTICS
  • Our statistical experts provide guidance in
    incorporating and analyzing the effectiveness of
    statistical methodologies in clinical trials,
    including our expertise in adaptive designs and
    Bayesian analysis. Our extensive experience
    allows us to develop a statistically rigorous and
    customized plan for each project. Biostatistical
    Services include,Study design, sample size
    estimation and authoring statistical sections of
    protocol. We also provide consulting services on
    Adaptive Designs, Bayesian analysis and
    personalized medicine approach trials. Some of
    our ad-hoc services include Interim Analysis
    Planning, Meta-analysis and Epidemiological
    Research.

3
  • EARLY DEVELOPMENT
  • Assist sponsors to fast track the drug
    development process. Genpro offers a wide range
    of early development services to assist sponsors
    to fast track the drug development process. Our
    trial design, statistics and data management
    expertise and experience helps us to meet
    clients needs.Our early development services
    range from medical writing, data management,
    biostatistics and trial design.
  • DATA SUBMISSION
  • Submission ready CDISC compliant data sets
    delivered on time. Genpros proven sas
    programming services combines industry best
    practices and ready to use macros developed by a
    very experienced team of SAS Programmers We have
    an elaborate set of SOPs and a full-time QA team
    which ensures in depth reviews and quality on
    time deliverables. Some of our submission
    services include
  • Raw Data Coversion.
  • CDISC (SDTM, ADaM and Define.XML).
  • eCTD validation and submission.
  • Pre-built validation macros.
  • REGULATORY INTERACTIONS
  • Genpro has extensive experience in interactions
    with regulatory agencies. We offer comprehensive
    regulatory advice to assist our clients in
    achieving success in the product approval process
    and post approval regulatory compliance. Some of
    our regulatory offerings include, Strategic
    planning and overall regulatory process
    management along with regulatory interactions
    and eCTD preparation

4
  • DMC SUPPORT
  • Independent Data Monitoring Committee (DMC)
    services are an integral and essential component
    of most of the clinical research programs. We
    provide essential statistical analyses required
    per the DMC charters and also participate in DMC
    boards. Our team provides independent statistical
    analysis of interim safety and efficacy data,
    comprehensive safety monitoring and preparation
    of DMC reports. We Develop DMC / Adaptive
    charters and perform data analysis and
    preparation of DMC reports, including safety
    analyses and interim efficacy results, conducted
    by an independent statistics/programming team.
    Presentation of results will be done by Ph.D.
    statisticians, as voting or non-voting members.
  • ADAPTIVE DESIGNS
  • Adaptive methodologies include Seamless Phase 2/3
    Designs,Group Sequential Designs, Adaptive Dose
    Response design etc. GenPro brings the expertise
    of designing and analysis of different types of
    adaptive methods to implement the most innovative
    clinical trials. Some of the adaptive
    methodologies include Seamless Phase 2/3
    Designs,Group Sequential Designs , Blinded and
    Unblinded Sample Size Re-estimation,Adaptive Dose
    Response design,Futility Stopping Designs,Dose
    Finding Designs and Bayesian Adaptive Designs.
  • BAYESIAN DESIGNS
  • Bayesian and Bayesian Adaptive Designs, used
    meta-analytic and modeling approaches. GenPro
    staff has extensive experience in the area of
    Bayesian Designs. They have been instrumental in
    designing several Bayesian and Bayesian Adaptive
    Designs, used meta-analytic and modeling
    approaches to reduce the sample size and led
    several discussions at FDA and EMA. They have
    been responsible for several PMA submissions
    using Bayesian approach.

5
Our Mission
  • Our mission is to support our clients in
    achieving their goals by providing knowledge
    driven innovative solutions with highest quality
    products and services.
  • WHO WE ARE
  • Genpro Research is a next-generation services and
    technology partner for the pharmaceutical,
    biotechnology, and medical devices industry. Our
    tools use Artificial Intelligence, Machine
    Learning, and Natural Language Processing
    algorithms to enable automation of several
    processes in a drug development pipeline.. We
    provide advanced solutions in Biostatistics
    Programming, Medical Writing, and Regulatory
    Submissions.

6
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