Strategic Consulting

Strategic Consulting

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.

Work Flow

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.

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.

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.

DATA SUBMISSION

Submission ready CDISC compliant data sets delivered on time. Genpro’s 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.

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.

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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