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* Regulatory Sciences
Expertise at every stage.
DevelopmentClinicalCommercial
Some of the specialized fields we support:
Medical Device and DiagnosticCell and Gene Therapy
OVERVIEW
FDA SERVICES: DRUG DEVELOPMENT
Regulatory Strategy/Gap AnalysisFDA Meeting Strategy and ExecutionFDA
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Clinical Research Solutions< See Clinical Research Solutions
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Biostatistics and Programming
BIOSTATISTICS AND PROGRAMMING
At ProPharma Group, we are a full-service and functional service provider
biometrics CRO. We offer a full suite of biostatistics and programming services
to support your clinical research needs across a variety of therapeutic areas
and specialties.
BIOSTATISTICS
Our Biostatisticians ensure your clinical study is designed correctly from the
start by calculating efficient sample sizes and selecting the most appropriate
statistical analysis methods for your clinical endpoints. In addition, our
Biostatisticians oversee your clinical trial from start to finish to ensure data
is collected correctly and is ready for analysis at the end of the study.
Our experience has taught us that regulatory agencies focus their reviews on the
presented statistical analyses, and our expert Biostatisticians ensure your
clinical study messaging is as clear and as accurate as possible.
PROGRAMMING
Our Statistical Programmers ensure all datasets and outputs required by
regulatory agencies are accurate and easily readable. All ProPharma Group
outputs that are submitted to regulatory agencies or publications are always
independently double programmed by two Statistical Programmers and reviewed by
at least two Statisticians to ensure acceptance by the regulatory authorities.
THERAPEUTIC AREAS
ProPharma Group’s Biostatistics and Programming experts can offer support for a
wide range of therapeutic areas. We have specific and recent experience with the
following: Oncology, Rare Disease, Vaccines, CNS, GI, Cardiovascular, and
Hematology among others.
ADDITIONAL SERVICES OUTSIDE OF THE CLINICAL TRIAL
In addition, we offer Statistics and Programming services for more than just
your clinical trial. We can and have supported clients with everything from
manuscript publications to New Drug Application (NDA)/Biologics License
Application (BLA) submissions and everything in between. We have supported
Health Economics and Outcomes Research (HEOR) as well as Real-World Evidence
(RWE) projects for our clients in addition to machine learning development and
expanded access data summarization.
Clinical Trials
* Study Design and Input
* Sample Size Calculation
* Adaptive design trials
* Analysis methods for primary, secondary, and exploratory endpoints
* Analysis Population definitions
* Protocol input (statistics section)
* Randomization scheme/plan
* Clinical Data Interchange Standards Consortium (CDISC) Dataset Creation (with
associated/required documentation)
* Study Data Tabulation Model (SDTM), including Specifications, Definitions,
and Reviewer’s Guide
* Analysis Data Model (ADaM), including Specifications, Definitions, and
Reviewer’s Guide
* Legacy Conversion (we can take your old non-CDISC study data and convert it
to CDISC compliant datasets for FDA submission)
* Statistical Analysis Plan Creation
* Shell creation of tables, listings, and figures (TLFs)
* Topline TLFs
* Final TLFs
* Clinical Study Report (CSR) review and input
Vendor Oversight
* When you have outsourced your trial to a Clinical Research Organization (CRO)
but do not have an in-house Statistician to review the CRO’s work, ProPharma
Group can provide an embedded team of Biostatisticians and Statistical
Programmers to review and oversee the CRO and answer their statistics and
programming related questions.
NDA/BLA
* Integrated Summary of Safety (ISS) SAP
* Integrated Summary of Efficacy (ISE) SAP
* Integration/pooling plan (SDTM or ADaM level)
* Study Data Standardization Plan input and discussions with agency
* Bioresearch Monitoring (BIMO) listings and ClinSite dataset creation
Data Safety Monitoring Board (DSMB)/Data Monitoring Committee (DMC)
* DSMB/DMC charter input
* Unblinded independent statistician support
* Unblinded output for DSMB
* Executive summary and meeting attendance
Development Safety Update Reports (DSUR) TLFs
* ProPharma Group’s statistics and programming team has extensive experience in
quickly and accurately compiling the reports required for your annual DSUR
reporting.
Investigator Brochure (IB) TLFs
* Providing meaningful information clearly to your investigators is one of the
most important things you can do for your IP. ProPharma Group’s
biostatisticians will work with you to formulate the best way to clearly
articulate the information you need to provide your investigators.
Manuscript Support and Input
* ProPharma Group’s statisticians can assist in the review and organization of
your data to provide suggestions for possible analyses to be included in
posters and publications.
* Support includes the creation of tables, listings, and figures to be included
in the poster or publication as well as the provision of statistical analysis
methodology and results text.
Real-World Evidence (RWE)
* We have extensive experience handling real-world evidence data. From claims
data to product registries, we can help analyze your RWE.
Health Economics and Outcomes Research (HEOR)
* ProPharma Group has robust experience in defining and developing cohorts to
make meaningful outcomes and economics claims.
Regulatory Agency meetings
* Prepare briefing books
* Data summarization
* Address agency questions
Contact Us
RELATED SERVICES
* Clinical Operations
* Clinical Data Management
* Medical Writing
* Peri and Post Approval Services (PPAS)
* Full Service CRO
* Decentralized Clinical Trials (DCTs)
* Functional Service Provision (FSP)
FIND OUT HOW WE CAN HELP YOU
Our experts are ready to tackle your challenge.
Request a Call
PRODUCT LIFECYCLE
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LIFECYCLE STAGE
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Olliver, Aske, Richmond, North Yorkshire, DL10 5HX, UK ProPharma Group MIS
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