biostatistics & programming

Enabling data-driven decision-making through precision analytics.

ProPharma's Biostatistics & Programming Expertise

At ProPharma, our biostatistics and programming team supports our clients through the entire product development journey and excels in transforming complex data into clear, actionable insights. Our global team ensures around-the-clock support and employs the latest industry standards, actively contributing to organizations like CDISC. We offer a comprehensive suite of services, from clinical study design and regulatory strategy support to clinical study execution, and provide real-time insights into what is happening with your data.

Utilizing advanced tools and languages like SAS, R, and Python, our team ensures high-quality, validated results. Our proven track record includes the successful completion of 10 NDA/BLA submissions in the past three years, demonstrating our commitment to excellence and regulatory compliance across a broad spectrum of therapeutic areas.

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Clinical Study Design

Clinical Study Design

Submissions

Regulatory Strategy

Regulatory Strategy

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Clinical Study Execution

Clinical Study Execution

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Additional Services

Additional Services

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Therapeutic Areas

Therapeutic Areas

Clinical Study Design Services

  • Endpoint Selection
  • Analysis Method Determination
  • Sample Size Calculations/Statistical Power (simulations, adaptive design, etc.)
  • Type 1 Error Rate Adjustments 
  • Adaptive Design 
  • Protocol Development (writing and QC) 
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Regulatory Strategy Support

  • General Statistical Guidance/Recommendation
  • Clinical Program Design and Development 
  • FDA Meeting Prep, Attendance, and Follow-up
  • FDA Submission (NDA, BLA, etc.) Strategy, Attendance (Representation), Advisory Committee Support, Ad-Hoc Support, etc.
  • Integrated Summary of Safety and Efficacy (ISS/ISE) for NDA and BLA Submission Support
  • Study Data Standardization Plans (SDSP)
  • Global Regulatory Support for all regulatory agencies (EMA, MHRA, PMDA, etc.) 
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Clinical Study Execution Services

  • Randomization (Plan, Codes, List, etc.) 
  • eCRF Design and Review 
  • Blinding (Plan, Maintenance, etc.) 
  • Statistical Analysis Plan (SAP) 
  • Table, Listing, Figure Shells (TLFs)
  • CDISC Programming, Validation, and Associated Documentation (SEND, SDTM, ADaM) 
  • Statistical Analysis with Formal + Validated Reports (CSR Input and Review)
  • Pharmacokinetic and Pharmacodynamic Analyses 
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Additional Services

  • Data Monitoring Committee (DMC) Services 
  • Health Economics and Outcomes Research (HEOR) 
  • Real World Evidence (RWE) 
  • Legacy CDSIC conversion data (SDTM and ADaM) 
  • Data Reconciliation 
  • Data Curation 
  • Data Visualization 
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Therapeutic Areas Served

We can support statistical analysis and programming for a variety of therapeutic areas, including:

  • Cardiovascular
  • Dermatology
  • Endocrinology
  • Geriatrics
  • GI
  • Hematology
  • Immunology
  • Infectious Disease
  • Inflammatory diseases
  • Neurology
  • Oncology
  • Ophthalmology
  • Pain Management
  • Pediatrics
  • Rare Disease
  • Respiratory
  • Rheumatology
  • Urology
  • Vaccines
  • Women's Health
  • And more
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Comprehensive Biostatistics & Programming Support and Consulting

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Clear Communication

We know that statistics and programming aren’t easily understood, and our team is here to help you know what’s going on with your data, in a way that makes sense and can be...

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Clear Communication

We know that statistics and programming aren’t easily understood, and our team is here to help you know what’s going on with your data, in a way that makes sense and can be explained to those outside the biostatistics and programming realm.

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CDISC Volunteers

We ensure our clients benefit from the most current and compliant practices in the field. Our team members volunteer at CDISC to develop and refine industry standards.

CDISC Volunteers

We ensure our clients benefit from the most current and compliant practices in the field. Our team members volunteer at CDISC to develop and refine industry standards.

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Experienced with Health Authorities

Our teams have vast experience communicating with regulatory agencies worldwide, including FDA, EMA, MHRA, PMDA, Health Canada, TGA, NMPA, and more. 

Experienced with Health Authorities

Our teams have vast experience communicating with regulatory agencies worldwide, including FDA, EMA, MHRA, PMDA, Health Canada, TGA, NMPA, and more. 

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NDA & BLA Submission Experience

We have completed 10 NDA/BLA submissions in the last 3 years. 

NDA & BLA Submission Experience

We have completed 10 NDA/BLA submissions in the last 3 years. 

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Global Team

Our team members are located in five countries across the globe, allowing us to work with our sponsors around the clock. 

Global Team

Our team members are located in five countries across the globe, allowing us to work with our sponsors around the clock. 

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Flexible Approach

Our flexible approach allows us to support our clients in whatever model best suits their needs, whether that is full-service CRO, functional service provider (FSP), or ad-hoc...

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Flexible Approach

Our flexible approach allows us to support our clients in whatever model best suits their needs, whether that is full-service CRO, functional service provider (FSP), or ad-hoc consulting. 

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Our Biostatistics & Programming Consulting and Services

At ProPharma, we redefine the landscape of biostatistics and programming by offering far more than mere statistical analysis. Our diverse team of experts delivers unparalleled support across the entire spectrum of the life sciences journey, ensuring that our clients benefit from a holistic and integrated approach. With best-in-class communication skills, we demystify complex statistical processes, ensuring they are accessible and transparent to all stakeholders. This approach facilitates informed decision-making at every level of engagement and fosters a collaborative environment where insights lead to innovation. 

Our global, highly experienced team operates across time zones, providing around-the-clock support to our sponsors. When combined with our robust processes and global infrastructure, we accelerate project timelines and enhance quality and consistency across deliverables, significantly mitigating risks and optimizing operational efficiencies. We are flexible to support our clients with an outsourcing model that best suits their needs, including full-service CRO, FSP, or ad-hoc consulting.

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Our Infrastructure & Tools

Quality and safety are at the heart of everything we do, especially when working with sensitive clinical trial data. Our team completes all work using our GXP-validated SAS server, and data is moved into and out of our environment through SFTPs.

We have programmers who are fluent in SAS, R, and Python languages, enabling us to work on any data type and conduct any data analysis needed. Our experienced team uses ProPharma's proprietary data visualization tool that enables our sponsors to view their data in real-time and to create their own graphics and dashboards providing them with key insights into their clinical trials in real-time.

Complex Needs Require Custom Solutions

We ensure that your statistical analysis is valid, complete, supported by the data, and presented in a way that is easy to understand. If you need support for your study data, ProPharma's experienced biostatistics and programming team can help. 

Biostatistics & Programming Experts

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News & Insights

Meet the Expert: David Lough

June 19, 2024

Meet the Expert: David Lough

Meet the Expert: David Lough, a Senior Pharmacovigilance Consultant at ProPharma, shares insights on PSMF and robust quality management systems.

An Overview of the PSMF: Pharmacovigilance System Master File

June 17, 2024

An Overview of the PSMF: Pharmacovigilance System Master File

Learn about the Pharmacovigilance System Master File (PSMF) in the EU, its history, structure, updates, and outsourcing options.

The GPO An Essential Guide to the Graduated Plan Officer (Der Stufenplanbeauftragte)

June 13, 2024

The GPO An Essential Guide to the Graduated Plan Officer (Der Stufenplanbeauftragte)

Read ProPharma's essential guide to the Graduated Plan Officer (GPO), outlining requirements, responsibilities, and local registration processes.

ProPharma Receives 2024 CRO Leadership Award

June 13, 2024

ProPharma Receives 2024 CRO Leadership Award

ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.

Revolutionizing Patient Care: ProPharma and PBL Launch Innovative Cell & Gene Therapy Manufacturing Device

May 2, 2024

Revolutionizing Patient Care: ProPharma and PBL Launch Innovative Cell & Gene Therapy Manufacturing Device

ProPharma and PBL introduce Cell Factory Box for decentralized Cell & Gene Therapies manufacturing, reducing costs and improving patient access to life-saving treatments.

ProPharma Now Certified as Medidata Rave EDC Accredited Partner

April 18, 2024

ProPharma Now Certified as Medidata Rave EDC Accredited Partner

ProPharma receives Medidata Rave EDC accreditation, enhancing clinical trial efficiency. Learn about the latest milestone delivering cutting-edge solutions.

ProPharma Receives 2024 CRO Leadership Award

June 13, 2024

ProPharma Receives 2024 CRO Leadership Award

ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.

EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

November 27, 2023

EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

Ernst & Young announces Michael Stomberg as a finalized for Entrepreneur Of The Year® 2023 National Award to celebrate ambitious entrepreneurs.

ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023

October 11, 2023

ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023

Everest Group has recognized ProPharma Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023.

Infographic The Cost of Poor Project Management - ProPharma

June 10, 2022

The Cost of Poor Project Management

Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...

Infographic Successfully Passing MHRA Inspections for Overseas Manufacturing Sites - ProPharma

August 31, 2022

Successfully Passing MHRA Inspections for Overseas Manufacturing Sites

ProPharma offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma’s Compliance and Quality team completed the first on-site...

Infographic Navigating the Generic Drug Application and Approval Process - ProPharma

October 4, 2021

Navigating the Generic Drug Application and Approval Process

Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug...

News & Insights

ProPharma Receives 2024 CRO Leadership Award

June 13, 2024

ProPharma Receives 2024 CRO Leadership Award

ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.

Revolutionizing Patient Care: ProPharma and PBL Launch Innovative Cell & Gene Therapy Manufacturing Device

May 2, 2024

Revolutionizing Patient Care: ProPharma and PBL Launch Innovative Cell & Gene Therapy Manufacturing Device

ProPharma and PBL introduce Cell Factory Box for decentralized Cell & Gene Therapies manufacturing, reducing costs and improving patient access to life-saving treatments.

ProPharma Now Certified as Medidata Rave EDC Accredited Partner

April 18, 2024

ProPharma Now Certified as Medidata Rave EDC Accredited Partner

ProPharma receives Medidata Rave EDC accreditation, enhancing clinical trial efficiency. Learn about the latest milestone delivering cutting-edge solutions.

Previous Post Arrow Next Post Arrow
ProPharma Receives 2024 CRO Leadership Award

June 13, 2024

ProPharma Receives 2024 CRO Leadership Award

ProPharma wins 2024 CRO Leadership Award for exceeding expectations in key categories, solidifying its position as a top global research consulting organization in the life sciences industry.

EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

November 27, 2023

EY Announces Michael Stomberg as an Entrepreneur Of the Year® 2023 National Finalist

Ernst & Young announces Michael Stomberg as a finalized for Entrepreneur Of The Year® 2023 National Award to celebrate ambitious entrepreneurs.

ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023

October 11, 2023

ProPharma Group Recognized by Everest Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023

Everest Group has recognized ProPharma Group as a Major Contender in Life Sciences Operations PEAK Matrix® Assessment 2023.

Previous Award Arrow Next Award Arrow
Meet the Expert: David Lough

June 19, 2024

Meet the Expert: David Lough

Meet the Expert: David Lough, a Senior Pharmacovigilance Consultant at ProPharma, shares insights on PSMF and robust quality management systems.

An Overview of the PSMF: Pharmacovigilance System Master File

June 17, 2024

An Overview of the PSMF: Pharmacovigilance System Master File

Learn about the Pharmacovigilance System Master File (PSMF) in the EU, its history, structure, updates, and outsourcing options.

The GPO An Essential Guide to the Graduated Plan Officer (Der Stufenplanbeauftragte)

June 13, 2024

The GPO An Essential Guide to the Graduated Plan Officer (Der Stufenplanbeauftragte)

Read ProPharma's essential guide to the Graduated Plan Officer (GPO), outlining requirements, responsibilities, and local registration processes.

Previous Post Arrow Next Post Arrow
Infographic The Cost of Poor Project Management - ProPharma

June 10, 2022

The Cost of Poor Project Management

Project Management isn’t for the faint of heart. There is a shockingly high rate of project failure… but on the other hand, great project management can be a key differentiator that leads a company...

Infographic Successfully Passing MHRA Inspections for Overseas Manufacturing Sites - ProPharma

August 31, 2022

Successfully Passing MHRA Inspections for Overseas Manufacturing Sites

ProPharma offers GMP and GDP compliance services from clinical development to commercial distribution of the products' lifecycle. ProPharma’s Compliance and Quality team completed the first on-site...

Infographic Navigating the Generic Drug Application and Approval Process - ProPharma

October 4, 2021

Navigating the Generic Drug Application and Approval Process

Navigating the generic drug application and approval process can be challenging. From pre-filing through post-approval, find out exactly what needs to be done for your Abbreviated New Drug...

Previous Resource Arrow Next Resource Arrow