Full-Service CRO
Services
As a trusted partner in clinical research, FDAMap brings 20+ years of expertise, seamlessly integrating with your
team to turn scientific breakthroughs into life-changing therapies.
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
FDAMap 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.
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.
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.
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.
Key Criteria for Selecting a CRO
When selecting a CRO, it is essential to consider several factors:
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.
- Oncology
- Neurology
- Infectious Disease
- Immunology
- Respiratory
- Psychiatry
- Endocrinology Metabolism
- Gastroenterology
- Cardiovascular
- Dermatology
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).
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.
- Study Start-up
- Trial Management
- Clinical Monitoring
- Data Management and Programming
- Medical Writing
- Biostatistics
- Pharmacovigilance
Tailored Solutions
The ability to provide customized solutions that fit the unique needs of each project is crucial for ensuring optimal outcomes.
Your Partner in Clinical Research
Connect with us today to discover how our 20 years of FDA success can guide your next project.
Comprehensive, Full-Service CRO Offerings and Services
Clinical Research Solutions
Comprehensive management of clinical trials, including site selection, patient recruitment, data management, and biostatistics.
Regulatory Sciences
Expertise in navigating the complex regulatory landscape, including preparing and submitting regulatory documents, ensuring compliance, and managing interactions with regulatory…
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,…
Quality & Compliance
Implementing and maintaining robust quality management systems to ensure the highest standards of compliance and quality.
Pharmacovigilance
Monitoring and reporting adverse events, ensuring patient safety, and maintaining compliance with regulatory requirements.
Medical Information
Providing accurate and timely medical information to support healthcare professionals and patients.
Full-Service CRO Solutions
- Clinical Pharmacology Consulting Expertise
- Regulatory Strategy, Operations, and Consulting
- Clinical Operations Expertise:
- Site Selection / Feasibility
- Clinical Monitoring Services
- eTMF and CTMS Support
- Site Training
- Study Conduct
- Clinical Program and Project Management
- Medical Monitoring
- Medical Writing
- Study Close
- Decentralized Clinical Trials, including global In-home Nursing, site staff augmentation solutions, and eSource capabilities.
- Clinical Data Sciences Expertise, including:
- Biostatistics and Programming
- Data Management
- Database Programming
Get Expert Guidance for your Clinical Development Needs
FDAMap’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.
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
Outsourcing Clinical Trials to CROs: Pros vs. Cons
When it comes to conducting clinical trials and managing regulatory affairs, many life sciences companies consider partnering with a Contract Research Organization (CRO).
How to Choose the Right CRO: 7 Key Factors to Evaluate
Choosing the right Contract Research Organization (CRO) is one of the most critical decisions a sponsor will make during a drug or device development program.
Top Benefits of Integrating Independent Physician Services with CRO Operations
As the landscape of clinical research becomes increasingly complex and patient-centric, Contract Research Organizations (CROs) are under pressure to deliver faster, more efficient, and high-quality results.
