Strategic consulting services in India - Genpro Research

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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.

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• 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.

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• 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

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• 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.

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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.

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