Full-Service CRO Services

As a trusted partner in clinical research, ProPharma brings 20+ years of expertise, seamlessly integrating with your team to turn scientific breakthroughs into life-changing therapies.

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Customizable, Scalable, Strategy-Led, Global Clinical Research Organization Services

Sponsors aim to move their products from development to commercialization as quickly and efficiently as possible. Traditionally, biotech, pharma, and MedTech companies have relied on the hope that the science will succeed and that a standard clinical research organization (CRO) model will get them to the finish line. However, with the evolving landscape, there's now a need for more personalization and agility—something that rigid CRO models typically don't offer.

CRO Services

ProPharma stands at the forefront of the clinical research organization industry, offering a comprehensive suite of services that span the entire drug, device and diagnostics development lifecycle. As a full-service CRO, ProPharma excels in providing end-to-end solutions, from early research to post-marketing surveillance. Our expertise encompasses Phase I-IV clinical research, regulatory sciences, pharmacovigilance, and quality assurance, ensuring that each project meets the highest standards of quality and compliance.

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Key Criteria for Selecting a CRO

When selecting a CRO, it is essential to consider several factors:

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Expertise and Experience

The CRO should have a proven track record in the therapeutic area relevant to the drug being developed. This includes expertise in handling complex development processes, particularly for biologics and cell and gene therapies.

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Quality Assurance and Regulatory Compliance

Ensure the CRO adheres to high standards of quality and compliance with regulatory requirements such as Good Laboratory Practice (GLP) and Good Clinical Practice (GCP).

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Comprehensive CRO Service Offerings

A top clinical research organization or CRO should offer a broad range of services that cover the entire drug development lifecycle, from early studies to post-marketing surveillance.

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Tailored Solutions

The ability to provide customized solutions that fit the unique needs of each project is crucial for ensuring optimal outcomes.

ProPharma: Full-Service CRO

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Full-Service CRO Capabilities

ProPharma’s client-focused approach ensures that every project benefits from our commitment to quality, innovation, and strategic consulting. Our dedication to improving patient health and safety drives their mission to deliver the technologies, medicines, and therapies of tomorrow.

ProPharma’s global reach and scalable solutions make us a reliable partner for both small startups and large pharmaceutical companies. By emphasizing strategic partnerships and bespoke solutions, ProPharma ensures that each client receives the support and expertise needed to navigate the complexities of drug and device development.

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Industry-Leading Support for Multiphase Clinical Development and Study Execution

ProPharma is a global provider of patient-focused clinical research solutions to the pharmaceutical, biotechnology, and medical device and diagnostic industries. We are experts, with experience across all study phases and in a diverse and wide range of therapeutic areas. Our shared attributes of innovation, expertise, and passion are at the heart of everything we do.

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Early Phase (Phase 1-2)

Early Phase (Phase 1-2)

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Late Phase (Phase 3 and Beyond)

Late Phase (Phase 3 and Beyond)

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Medical Device & Diagnostics

Medical Device & Diagnostics

Early Phase (Phase 1-2) CRO Services

Quick completion of Phase 1-2 trials to meet proof of concept goals is critical. We provide clinical expertise and an extended suite of early phase clinical development services specifically engineered to accelerate study progression.

Our integrated regulatory, pharmacology, statistics, and clinical experts design protocols that address and generate the data you need to make go and no-go decisions.

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Late Phase (Phase 3 and Beyond)

We can develop and execute the global plans to move you forward – from reviewing and managing ongoing efficacy and safety data to generating real-world evidence to support pricing agreements. Our regulatory, clinical, and medical affairs experts know what you need. We are committed to delivering the strategy and market solutions you need to be successful.

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Medical Device & Diagnostics

ProPharma has a unique combination of experience across the Medical Device Trial Space that drives the successful conduct of Medical Device and Diagnostic study. Our staff offers extensive experience in conducting First in Human/Feasibility, Pilot, Pivotal, and Post-Market Approval Studies.

Within the device trial space, our experience ranges across several medical device research trials including but not limited to:

  • Various cardiovascular trials, particularly in surgical settings
  • Urology devices
  • Orthopedic devices
  • Intravascular renal system devices
  • Respiratory treatment devices
  • Hemostatic devices

This experience spans across all functional areas – from operationalizing the trial at the study site level to managing the data through data management and analyzing the data through Biostatistics. We are well-versed in the data that is collected and summarized within device studies.

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Your Partner in Clinical Research

ProPharma offers a wide range of CRO services designed to support clients throughout the drug development process.

Comprehensive, Full-Service CRO Offerings and Services

clinicalResearch

Clinical Research Solutions

Comprehensive management of clinical trials, including site selection, patient recruitment, data management, and biostatistics.

Clinical Research Solutions

Comprehensive management of clinical trials, including site selection, patient recruitment, data management, and biostatistics.

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Regulatory Sciences

Expertise in navigating the complex regulatory landscape, including preparing and submitting regulatory documents, ensuring compliance, and managing interactions with regulatory...

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Regulatory Sciences

Expertise in navigating the complex regulatory landscape, including preparing and submitting regulatory documents, ensuring compliance, and managing interactions with regulatory authorities.

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RandD

Research & Development

ProPharma's R&D Technology team offers a full range of strategic and technical consulting services, including technology road-mapping, digital blueprints, system integration,...

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Research & Development

ProPharma's R&D Technology team offers a full range of strategic and technical consulting services, including technology road-mapping, digital blueprints, system integration, data migration, clinical system selection, implementation and validation, and post-production support.

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Quality

Quality & Compliance

Implementing and maintaining robust quality management systems to ensure the highest standards of compliance and quality.

Quality & Compliance

Implementing and maintaining robust quality management systems to ensure the highest standards of compliance and quality.

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Pharmacovigilance

Monitoring and reporting adverse events, ensuring patient safety, and maintaining compliance with regulatory requirements.

Pharmacovigilance

Monitoring and reporting adverse events, ensuring patient safety, and maintaining compliance with regulatory requirements.

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Medical Information

Providing accurate and timely medical information to support healthcare professionals and patients.

Medical Information

Providing accurate and timely medical information to support healthcare professionals and patients.

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Full-Service CRO Solutions

Get Expert Guidance for your Clinical Development Needs

ProPharma’s comprehensive CRO service offerings and strategic approach enables pharmaceutical, biotechnology, medical device and diagnostics companies to bring new drugs and therapies to market efficiently and effectively.

As a full-service clinical research organization, ProPharma connects your clinical aspirations with our deep scientific and medical expertise, strong therapeutic insights, and unmatched clinical development experience to help you bring high-quality therapies to market fast – always with the patients’ safety in mind.

Our dedication to client success, quality, and innovation, we ensure that each project is tailored to meet specific needs, resulting in optimal outcomes and a higher probability of success.

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What is a CRO?

Clinical Research Organizations (CROs), also referred to as Contract Research Organizations, provide specialized research services to pharmaceutical, biotechnology and medtech companies. These organizations support the development and approval of new drugs and medical devices through a wide range of services, including clinical research, data management, regulatory affairs, and quality assurance.

Importance of CROs in Drug Development

CROs play a crucial role in drug development by offering cost-effective and time-efficient services compared to in-house research. They provide expertise across various stages of drug development, from early-stage laboratory research to late-stage clinical trials. For emerging pharmaceutical, biotech, and medical device organizations, CROs can significantly reduce the time and expense involved in bringing a new drug to market.

What is a CRO?

Clinical Research Organizations (CROs), also referred to as Contract Research Organizations, provide specialized research services to pharmaceutical, biotechnology and medtech companies. These organizations support the development and approval of new drugs and medical devices through a wide range of services, including clinical research, data management, regulatory affairs, and quality assurance.

Importance of CROs in Drug Development

CROs play a crucial role in drug development by offering cost-effective and time-efficient services compared to in-house research. They provide expertise across various stages of drug development, from early-stage laboratory research to late-stage clinical trials. For emerging pharmaceutical, biotech, and medical device organizations, CROs can significantly reduce the time and expense involved in bringing a new drug to market.

Featured CRO Articles

Pros and Cons of Working with a CRO

Pros and Cons of Working with a CRO

Sponsors may transfer any or all of their many tasks and obligations relating to clinical trials to Contract Research Organizations (CROs). This ability to delegate through a Transfer of Regulatory...

7 Things to Consider Before Selecting a CRO

7 Things to Consider Before Selecting a CRO

Selecting the right contract research organization (CRO) is one of the most important decisions you, as a sponsor, must make. That’s because CROs can improve efficiency and increase productivity,...

Enhancing CRO Capabilities with Independent Physician Services

Enhancing CRO Capabilities with Independent Physician Services

The involvement of Medical Monitoring (MM) and Data Safety Monitoring Boards (DSMB) in trials has been somewhat unknown to individuals outside of clinical circles. That is, until media attention...

News & Insights

Understanding the Roles of LPPV, QPPV, and the PSMF in Pharmacovigilance: A Guide for Marketing Authorization Holders (MAHs)

July 25, 2025

Understanding the Roles of LPPV, QPPV, and the PSMF in Pharmacovigilance: A Guid...

Learn about the crucial roles of QPPV, LPPV, and PSMF in ensuring effective pharmacovigilance and regulatory compliance for Marketing Authorization Holders (MAHs).

FDA Publishes over 200 Complete Response Letters (CRLs)

July 24, 2025

FDA Publishes over 200 Complete Response Letters (CRLs)

FDA's new transparency with over 200 CRLs empowers sponsors to navigate regulatory challenges more effectively, accelerating drug approvals and enhancing patient access to treatments.

Navigating EMA and Global Regulations for Medical Information Services

July 24, 2025

Navigating EMA and Global Regulations for Medical Information Services

ProPharma guides clients through global medical information regulatory landscapes, ensuring compliance and excellence across markets with tailored solutions, AI integration, and continuous training.

ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice President, Labeling & Strategy to Advance Strategic Labeling & Promotional Review

July 8, 2025

ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice Presid...

ProPharma appoints former FDA labeling expert as VP, Labeling & Strategy, enhancing strategic labeling, promotional review, and regulatory consulting expertise to accelerate drug development and...

ProPharma Recognized for AI Excellence at ECCCSA

January 31, 2025

ProPharma Recognized for AI Excellence at ECCCSA

ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.

ProPharma Appoints Brian Tuttle as Chief Financial Officer

October 21, 2024

ProPharma Appoints Brian Tuttle as Chief Financial Officer

ProPharma appoints Brian Tuttle as CFO to drive financial strategy and accelerate global growth, leveraging his 20 years of life sciences industry experience.

ProPharma Recognized for AI Excellence at ECCCSA

January 31, 2025

ProPharma Recognized for AI Excellence at ECCCSA

ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

October 9, 2024

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

September 24, 2024

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.

Case Study From Drafts to First Patient in Record Time - ProPharma

July 8, 2025

From Drafts to First Patient in Record Time

Launching a global clinical study from draft documents, the team achieved US first patient in in 3.5 months and met ambitious global submission timelines. Strong collaboration, proactive planning,...

Whitepapers FDA Pre-IND Meetings: Setting Yourself up For a Successful 505(b)(2) NDA Submission

June 23, 2025

FDA Pre-IND Meetings: Setting Yourself up For a Successful 505(b)(2) NDA Submiss...

A Strategic Guide to Early FDA Engagement for a Streamlined NDA Pathway For drug developers leveraging the 505(b)(2) NDA pathway, early engagement with FDA is a critical determinant of regulatory...

Case Study Local Expertise, Local Knowledge: MAH in Bosnia and Herzegovina - ProPharma

June 18, 2025

Local Expertise, Local Knowledge: MAH in Bosnia and Herzegovina

Acting as Marketing Authorization Holder in Bosnia and Herzegovina, Clinres—a ProPharma company—helped a global pharma client overcome regulatory delays, misaligned planning, and seasonal launch...

Avoiding Common Pitfalls During FDA Inspections

July 29, 2025

Avoiding Common Pitfalls During FDA Inspections

Starting August 2025, the FDA will conduct unannounced inspections at non-U.S. sites. This webinar explores common inspection pitfalls and how to maintain global inspection readiness with expert...

Inside FDA Review: Crafting a Quality ANDA Labeling Submission

July 22, 2025

Inside FDA Review: Crafting a Quality ANDA Labeling Submission

Gain rare, insider insight into the FDA’s expectations for ANDA submissions in this session led by Marshall Florence, PharmD, a former FDA reviewer who recently joined our team. With firsthand...

MAH Essentials: Ensuring Compliance for European Market Entry

July 10, 2025

MAH Essentials: Ensuring Compliance for European Market Entry

This webinar covers the key responsibilities of Marketing Authorization Applicants/Holders and Qualified Persons in the EEA/UK, including pharmacovigilance requirements, legal entity setup, and...

News & Insights

Understanding the Roles of LPPV, QPPV, and the PSMF in Pharmacovigilance: A Guide for Marketing Authorization Holders (MAHs)

July 25, 2025

Understanding the Roles of LPPV, QPPV, and the PSMF in Pharmacovigilance: A Guid...

Learn about the crucial roles of QPPV, LPPV, and PSMF in ensuring effective pharmacovigilance and regulatory compliance for Marketing Authorization Holders (MAHs).

FDA Publishes over 200 Complete Response Letters (CRLs)

July 24, 2025

FDA Publishes over 200 Complete Response Letters (CRLs)

FDA's new transparency with over 200 CRLs empowers sponsors to navigate regulatory challenges more effectively, accelerating drug approvals and enhancing patient access to treatments.

Navigating EMA and Global Regulations for Medical Information Services

July 24, 2025

Navigating EMA and Global Regulations for Medical Information Services

ProPharma guides clients through global medical information regulatory landscapes, ensuring compliance and excellence across markets with tailored solutions, AI integration, and continuous training.

Previous Post Arrow Next Post Arrow
ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice President, Labeling & Strategy to Advance Strategic Labeling & Promotional Review

July 8, 2025

ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice Presid...

ProPharma appoints former FDA labeling expert as VP, Labeling & Strategy, enhancing strategic labeling, promotional review, and regulatory consulting expertise to accelerate drug development and...

ProPharma Recognized for AI Excellence at ECCCSA

January 31, 2025

ProPharma Recognized for AI Excellence at ECCCSA

ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.

ProPharma Appoints Brian Tuttle as Chief Financial Officer

October 21, 2024

ProPharma Appoints Brian Tuttle as Chief Financial Officer

ProPharma appoints Brian Tuttle as CFO to drive financial strategy and accelerate global growth, leveraging his 20 years of life sciences industry experience.

Previous Post Arrow Next Post Arrow
ProPharma Recognized for AI Excellence at ECCCSA

January 31, 2025

ProPharma Recognized for AI Excellence at ECCCSA

ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

October 9, 2024

ProPharma Receives 2024 CPHI Regulatory and Compliance Award

ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

September 24, 2024

ProPharma Honored in the 2024 Clinical Trials Excellence Awards

ProPharma honored with Clinical Trials Excellence Award 2024, recognizing their outstanding contributions in the pharmaceutical industry.

Previous Award Arrow Next Award Arrow
Case Study From Drafts to First Patient in Record Time - ProPharma

July 8, 2025

From Drafts to First Patient in Record Time

Launching a global clinical study from draft documents, the team achieved US first patient in in 3.5 months and met ambitious global submission timelines. Strong collaboration, proactive planning,...

Whitepapers FDA Pre-IND Meetings: Setting Yourself up For a Successful 505(b)(2) NDA Submission

June 23, 2025

FDA Pre-IND Meetings: Setting Yourself up For a Successful 505(b)(2) NDA Submiss...

A Strategic Guide to Early FDA Engagement for a Streamlined NDA Pathway For drug developers leveraging the 505(b)(2) NDA pathway, early engagement with FDA is a critical determinant of regulatory...

Case Study Local Expertise, Local Knowledge: MAH in Bosnia and Herzegovina - ProPharma

June 18, 2025

Local Expertise, Local Knowledge: MAH in Bosnia and Herzegovina

Acting as Marketing Authorization Holder in Bosnia and Herzegovina, Clinres—a ProPharma company—helped a global pharma client overcome regulatory delays, misaligned planning, and seasonal launch...

Previous Resource Arrow Next Resource Arrow
Avoiding Common Pitfalls During FDA Inspections

July 29, 2025

Avoiding Common Pitfalls During FDA Inspections

Starting August 2025, the FDA will conduct unannounced inspections at non-U.S. sites. This webinar explores common inspection pitfalls and how to maintain global inspection readiness with expert...

Inside FDA Review: Crafting a Quality ANDA Labeling Submission

July 22, 2025

Inside FDA Review: Crafting a Quality ANDA Labeling Submission

Gain rare, insider insight into the FDA’s expectations for ANDA submissions in this session led by Marshall Florence, PharmD, a former FDA reviewer who recently joined our team. With firsthand...

MAH Essentials: Ensuring Compliance for European Market Entry

July 10, 2025

MAH Essentials: Ensuring Compliance for European Market Entry

This webinar covers the key responsibilities of Marketing Authorization Applicants/Holders and Qualified Persons in the EEA/UK, including pharmacovigilance requirements, legal entity setup, and...

Previous Webinar Arrow Next Webinar Arrow