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Global MedTech Solutions

Our experts understand what it takes to get these products to market and help                                                                          design efficient and compliant trials as needed to help meet your goals.

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RCO

Global MedTech Solutions

Our experts understand what it takes to get these products to market and help                                                                          design efficient and compliant trials as needed to help meet your goals.

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RCO

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MedTech Services

From concept development through Food and Drug Administration (FDA), international regulatory submissions, and European Union (EU), our team of specialists is highly qualified to assist you in all aspects of medical device and diagnostic regulation throughout the product lifecycle. If you are in process of developing an  regulated product, our experienced team of specialists can help you achieve successful regulatory outcomes, globally. We work in the most expeditious way possible to help you realize the value of those outcomes sooner.

All MedTech Services

The regulatory path for medical devices and diagnostics is different from drug development, which is why we have a dedicated team of experts who focus solely on supporting our device and diagnostics clients.

MedTech Product Development & CRO Services

Clinical Trials

ProPharma MedTech offers a full range of CRO services for first-in-human and early feasibility studies, nonsignificant risk studies, multicenter pivotal trials to support regulatory approvals, usability and human factors studies, and post-market studies to support reimbursement determinations, marketing objectives, or as required to maintain CE marking or as a condition of regulatory approval. We support our clients through FDA audits of investigational sites and have successfully passed multiple FDA audits of studies we have managed. 

Global Medtech CRO Services:

  • Protocol/ Medical Writing
  • Clinical Trial Site Selection & Qualification
  • Clinical Trial Budgets & Negotiations
  • Clinical Study Start-up & Patient Recruitment
  • Clinical Trial Monitoring & Site Management
  • Clinical Data Management & Biostatistics
  • Clinical Trial Vendor management
  • Clinical Trial Management Systems
  • Clinical Safety Management (DSMB/CEC)
  • Clinical & Regulatory Audit Preparation and Support
  • Post Market Studies
  • Human Factor/Usability Study Management
  • Clinical Quality Assurance

Our clinical experts routinely work with ProPharma’s regulatory experts to provide strategy and support for IDE’s, interact with FDA during the review process, and arrange and participate in pre-submission meetings. Having a long history of receiving FDA Investigational Device Exemption (IDE) approvals and have served as the Contract Research Organization (CRO) for countless studies to support 510(k), de novo and PMA applications, as well as CE marking. 

Clinical Study Global Expertise:

  • Enhanced bone void filler for multiple applications 
  • Type II diabetes management device
  • Lumbar and cervical disc replacement devices
  • HIFU system to treat prostate cancer
  • Cardiac ablation for atrial fibrillation
  • UV blood irradiation for HIV
  • Noninvasive vagus nerve stimulator (multiple indications)
  • Total Hip Replacement System
  • MIS ablation procedure for low back pain
  • Wearable spine rehabilitation device
  • Shockwave treatment for non-unions, sports injuries, wound healing in OA
  • HPV testing in cervical cancer
  • In vitro human embryo development
  • Electrical bone growth stimulator
  • Diagnostic product for detection of skin melanoma
  • Hydrogel nucleus replacement device
  • Wearable software device for Atrial Fib
  • Cell harvesting device for knee OA indications

Digital Health

Software Functions and SaMD

ProPharma's industry-leading MedTech professionals provide guidance on software-related questions to support clients of all sies. We partner with you to ensure delivery of documentation that meets regulatory expectations and facilitate successful premarket submissions.

Software products are used in a variety of healthcare applications including tracking personal health and well-being, monitoring vital signs, administering therapies, facilitating diagnoses and treatment decisions, and aiding with surgical procedures. Our experts can advise on how to determine whether a software function and/or product meets the definition of a medical device (SaMD or SiMD) that is subject to FDA regulatory oversight. We can also lead strategies for potential pathways for bringing these software products to market, along with points to consider in developing short and long-term regulatory strategies. Our SaMD experts can also work to advise you on development of algorithm training and validation strategies and how clinical data expectations may be impacted by the selected regulatory pathway.

Areas of Focus

  • Regulatory Assessments
  • FDA Submissions
  • QMS Development
  • Post-Market Change Control Assessments

Medical Device Software Considerations

  • Classification: Determine classification as software or device. Assess and develop regulatory pathway based on software claims and functionality. Prepare and lead regulatory submissions to FDA and OUS regulatory agencies.
  • Software Training and Validation Requirements: Advise on training and validation activities of AI/ML-based algorithms.
  • Cybersecurity Requirements: Advise and support development of cybersecurity risk management file.
  • QMS-SDLC Interaction: Develop QMS integrating SDLC processes and assist with building SW Design History File.
  • Post-Market Software Changes: Assess regulatory impact of post-market software changes, determine which require FDA review, and develop roadmap.

In Vitro Diagnostics (IVD)

In vitro diagnostics (IVD) products are medical devices that are intended for use in the diagnosis of disease or other medical conditions and assessing the current state of patient health. This unique subset of medical device includes reagents, instruments, software, and associated components that often work together as a system to achieve the design intent. ProPharma has expertise in the specific challenges that IVD manufacturers face in integrating the laboratory sciences with the engineering aspects of physical devices and instrumentation. We understand the entire IVD product lifecycle and can guide our clients through design and commercialization, manufacturing, and post market surveillance and reporting.

two-technicians-using-petri-dishes-and-test-tubes

 

IVD Areas of Focus:

  • Molecular Diagnostics
  • Companion Diagnostics
  • Point of Care Testing (POCT)
  • Immunoassays
  • Naval Assays
  • Near Patient/Self Testing

In addition to a full suite of quality solutions, we support our clients with regulatory strategy and submission capabilities for the US and international markets. We also provide gap assessments and preparation services for transition from EU IVDD to IVDR.

Medical Device Consulting

Our team of seasoned experts assist in all matters concerning the regulation and compliance of your medical device or combination product.. At each step in the development of your medical device, you will gain new information and data that will construct and change the steps that follow. As this happens, your regulatory strategy will transform as well. We work with you to integrate any new information into your overall plan, even if we didn’t develop the initial strategy. We will audit and adjust your regulatory strategy to optimize the pathway to approval for your medical device.

ProPharma has a full range consulting capabilities across the globe, including an all-inclusive medical device consulting service offering. Our medical device consulting capabilities include all regulatory, clinical and quality compliance aspects of device, diagnostic and combination product development. We have experience with medical devices across all classes and spanning a diverse range of indications and therapeutic areas. Our emphasis on science, coupled with the technical expertise of our medical device experts, allows us to effectively communicate with regulatory authorities in support of your product.

Regardless of where you are in the development, approval or commercialization of your medical device, we can help. We take a proprietary approach to strategy development, combining deep and broad scientific knowledge with extensive regulatory, clinical and quality experience. This method has proven successful for decades, as we have assisted our clients in achieving regulatory approvals, clinical study execution and quality management system support for more than 23 years. 

Clinical Evaluation Reports (CERs) / Clinical Evaluation Plans (CEPs)

With local, regional, and global capabilities, ProPharma’s team of experienced MedTech professionals support clients of all sizes to deliver CERs that meet and exceed regulatory standards. 

As the world's largest RCO (Research Consulting Organization), we deliver results through an Advise | Build | Operate model to ensure data quality, reliability, regulatory compliance, and industry-leading language and writing expertise.  

665

CERs Delivered

10+

Years Delivering CERs

40%+

Leading Clients

30%+

Start-Up | Early Stage

Clinical Evaluation Reports

  • Clinical Evaluation Plan: Systematic approach & strategy, including a roadmap for conducting evaluations from development to post-market surveillance.
  • Literature Search & Review: Identify & review relevant data obtained through literature searching to address safety, performance, side effects & risk-benefit analysis questions.
  • Analysis/Appraisal of Clinical Data: Systematically analyze, interpret, and synthesize data. Plan and document the assessment for suitability, scientific validity, and contribution to the overall dataset.
  • Post-Market Clinical Follow-Up (PMCF): Identify residual risks & gather long-term clinical performance data for better understanding.
  • Clinical Study Execution: Design, plan, and execute experiments for interventional studies, surveys, registries & observational research.
  • Demonstration of Equivalence: Identify & demonstrate the equivalence of an alternative device when appropriate for technical, biological & clinical evaluation.

Global Medical Device Regulatory Support

ProPharma Group is an established partner with a large segment of the med tech industry ranging from small entrepreneurial start-ups to multinational device manufacturers. The company is a trusted advisor in providing clients comprehensive strategic solutions for complex regulatory challenges that are commonly associated with getting the most ground-breaking technologies from concept to market. With a corporate culture that fosters innovative thinking, we take care to understand each client's US, EU and global marketing objectives; this provides assurance that the regulatory and clinical strategy complement client plans for global regulatory agency review and international commercialization.

It is essential to have a strategic and well thought-out plan when preparing to approach regulatory bodies seeking approval of your medical device. Each interaction with an agency should be carefully and tactically organized to maximize the information gained at each step of the development process. A sound regulatory strategy provides an actionable roadmap that you need.

Each company and product are unique. Accordingly, the journey taken to obtain FDA approval for your medical device will also be unique. We understand this and develop customized regulatory strategies for every company and every product, focusing on each client’s individual needs.

Regulatory affairs services range from support at earlier stages of product development for pre-submission meetings to formal preparation of 510(k)s and de novo petitions, IDEs, HDEs, and PMAs. International specialists have extensive experience in the selection of Notified Bodies, preparation of Technical Files and Dossiers for CE marking under EU MDR and global regulatory submissions.

Quality Systems & Regulatory Compliance

Based in the US & EU, ProPharma’s industry-leading MedTech subject matter experts support clients with FDA 483s, Warning Letters, Recalls, Competent Authority, and NB Non-Conformances.

ProPharma’s Quality Systems specialists help design and prepare Quality Management Systems (QMS) and SOPs compliant with FDA, MDR and international regulations, support clients through FDA/ISO and Notified Body audits as well as assistance in resolution of compliance issues such as 483 observations and Warning Letters. Our specialists also provide guidance for MDSAP certification.


50+

FDA 483 Resolutions

10+

Years Remediation Experience

40+

Competent Authority & NB Remediations


MedTech Experts

Global Medtech Experts. Deep Domain Expertise.

ron-freeze-propharma

Ron Freeze

Global Head Of Medical Technology

1516620849042

Tina Hudson

Director, Diagnostic and Combination Products

1516932196565

Joyce Ludwig

Quality Project Manager

Kristin Robinson

Kristin Robinson

Senior Project Manager - Clinical Research Solutions

1517756092820

Jennifer Daudelin

Senior Project Manager - Clinical Research Solutions

MedTech Resources

Pathways to Market for Medical Devices in the U.S.

Medical devices are regulated by the Center for Devices and Radiological Health (CDRH) at the FDA. Which approval pathway is appropriate for your product? You have developed a medical device and are...

Navigating QMS Requirements from a Medical Device Perspective

Having a different number of pharmaceutical classified products in your portfolio provides a challenge in EU. As distribution and sales of MD products are under MDR, while pharmaceuticals are under...

How to Manage a Drug Product in a Medical Device Environment

A global medical device company asked ProPharma to assess the set-up of the entire supply chain of a drug product. We did so by reviewing the Global Quality Management System and we determined how it...

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ProPharma Group Named Top 10 CRO 2022 by Pharma Tech Outlook

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ProPharma Group Named Top 10 CRO 2022 by Pharma Tech Outlook

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March 21, 2022

Reduced Burden for Oncology Patients With Decentralized Visits

Learn how our team helped implement decentralized visits for an oncology study that reduced patient burden and stress on the sites. Oncology studies often require frequent sample collection visits....

Videos AI-Powered Medical Information Contact Centers: Key Considerations for a Scalable & Global Medical Information Capability - ProPharma

February 4, 2022

AI-Powered Medical Information Contact Centers: Key Considerations for a Scalable & Global Medical Information Capability

AI can enable MI Contact Centers to transform the customer experience using digital avenues. Join us for our upcoming Insider Talks to find out!

Case Study Secure Timely Product Launch by Ensuring GDP Compliance Across Europe - ProPharma

October 14, 2021

Secure Timely Product Launch by Ensuring GDP Compliance Across Europe

Our client was in the phase of submitting a Marketing Authorization Application (MAA) in the EU and needed to apply for a Wholesale Distribution Authorization (WDA). After application and approval of...

Case Study Sponsor Successfully Completes Acquisition After Efficient PMA Submission - ProPharma

July 26, 2022

Sponsor Successfully Completes Acquisition After Efficient PMA Submission

A major Top 10 Medical Device Sponsor engaged M2, a ProPharma company, to collaborate and support innovation to reduce complexity associated with a successful PMA submission. Learn how ProPharma...

Case Study Statistical Analytics with Machine Learning Tool Enablement - ProPharma

October 14, 2021

Statistical Analytics with Machine Learning Tool Enablement

Introducing new tools is difficult and comes with a learning curve for even the most experienced, and having clearly defined processes and procedures is critical to your team’s success. If there is...

Videos 20 Years of Improving Patient Health and Safety - ProPharma

January 25, 2022

20 Years of Improving Patient Health and Safety

With our mission to improve the health and safety of patients, we are focused on delivering the highest quality of services throughout the full product lifecycle.

Case Study Supporting Decentralized Gene Therapy Visits - ProPharma

February 17, 2022

Supporting Decentralized Gene Therapy Visits

Clinical trials often require frequent visits to the investigative site and procedures which can be a turn-off or become the reason many patients cannot commit their time to participate in a study....

Videos Cohort Management Process and Planning: Challenges, Risks, and Mitigations - ProPharma

December 7, 2021

Cohort Management Process and Planning: Challenges, Risks, and Mitigations

Learn novel and useful drug design methodologies based on ProPharma's years of experience navigating the risks, issues, and difficulties associated with various cohort design studies.

Videos Expedited Programs Explained: How to Expedite Product Approval in the US and Europe - ProPharma

November 12, 2021

Expedited Programs Explained: How to Expedite Product Approval in the US and Europe

Could your product be eligible for one of these expedited programs? Join us for our upcoming Insider Talks to find out!

Case Study Transfer and Manage Clinical Data Provided by Multiple Third-Party Vendors - ProPharma

October 14, 2021

Transfer and Manage Clinical Data Provided by Multiple Third-Party Vendors

Managing and sharing large amounts of clinical data provided by a team of ten plus vendors is extremely challenging and requires meticulous attention to detail and expert-level project management to...

Videos What Does it Take to Build a Legacy? (20th Anniversary Video) - ProPharma

October 15, 2021

What Does it Take to Build a Legacy? (20th Anniversary Video)

Case Study Understanding Clinical Trial Requirements for Medical Device Label Extensions - ProPharma

October 14, 2021

Understanding Clinical Trial Requirements for Medical Device Label Extensions

After you have developed an FDA-regulated product and obtained marketing approval, you may think your job is done. However, after all the time, effort, money, and so much more that goes into product...

Case Study Using Science to Achieve EMA Approval for a First-in-Class Indication - ProPharma

October 14, 2021

Using Science to Achieve EMA Approval for a First-in-Class Indication

See how a scientifically-driven strategy aided regulatory interactions, leading to EMA approval for a novel oncology therapeutic. You’re developing a drug, biologic, or medical device product. Your...

Videos The True Cost of Non-Compliance - ProPharma

October 13, 2021

The True Cost of Non-Compliance

How to avoid getting your first, second, and third warning letter from a federal agency.

Case Study When a Team Lacks Industry Experience - ProPharma

October 14, 2021

When a Team Lacks Industry Experience

Working with a team from three organizations across the globe is hard. Unifying them required experts to take the lead. Working with a team that is spread across the globe and made up of people from...

Case Study When a Team Loses Their Leader and Lacks a Plan - ProPharma

October 14, 2021

When a Team Loses Their Leader and Lacks a Plan

Projects spanning multiple functions across an organization can be difficult to execute and require the leadership of an experienced and organized project manager. But what happens if the project...

Videos ProPharma Overview Video  - ProPharma

October 4, 2021

ProPharma Overview Video

With our mission to improve the health and safety of patients, we are focused on delivering the highest quality of services throughout the full product lifecycle.

Guide Assess Your Readiness for Supplying Drug Product to Europe and UK

June 16, 2023

Evaluate Readiness and Compliance for Supplying Drug Product to EU/UK/EEC

Assessing your progress is of utmost importance when supplying pharmaceutical products to the European Union (EU), United Kingdom (UK), and European Economic Community (EEC), as it ensures compliance...

Whitepapers Meeting the FDA's CAPA Expectations - ProPharma

March 21, 2022

Meeting the FDA's CAPA Expectations

Year after year, findings of insufficient corrective and preventative action (CAPA) procedures have topped the list of the most common observations found during FDA inspections within the medical...

Whitepapers What You Need to Know About Regulatory Programs for Expedited Approval - ProPharma

December 2, 2023

What You Need to Know About Regulatory Programs for Expedited Approval

Differentiating between the FDA and EMA's expedited approval pathways can be tricky. Learn the similarities and differences between them to help determine the best option(s) for your product. The...

Flyers EU IVDR Progress Self Assessment - ProPharma

February 3, 2022

EU IVDR Progress Self Assessment

The deadline for EU IVDR is May 26, 2022. Use this readiness questionnaire to assess the current state of your progress.

Flyers EMA Services: Ensure Regulatory Success - ProPharma

October 14, 2021

EMA Services: Ensure Regulatory Success

Ensure Regulatory Success Across the European Medicines Agency (EMA) and National Competent Authorities (NCAs)

Flyers Accelerating Your Product Through Drug Development - ProPharma

December 2, 2023

Accelerating Your Product Through Drug Development

Reducing Risk, Ensuring Compliance, and Accelerating Access for Patients

Flyers Cell and Gene Therapy Center of Excellence - ProPharma

October 14, 2021

Cell and Gene Therapy Center of Excellence

Accelerating Your Product Through Development: Reducing Risk Ensuring Compliance, and Accelerating Access for Patients

Flyers Data Integrity: The Quality of Your Product Depends on The Quality of Your Data - ProPharma

October 14, 2021

Data Integrity: The Quality of Your Product Depends on The Quality of Your Data

Regulatory Agencies Expect Controls to Be in Place

Flyers FDA Consulting: Regulatory Strategy Expertise - ProPharma

October 14, 2021

FDA Consulting: Regulatory Strategy Expertise

Reduce Your Time to Market With an Effective FDA Regulatory Strategy

Flyers ProPharma Services Overview - ProPharma

October 4, 2021

ProPharma Services Overview

Improving Patient Health and Safety. At Every Step.

Flyers Medical Device Development from ProPharma

October 4, 2021

Medical Device Development

Navigate Complex Global Requirements for Medical Device Approval

Flyers EU Market Access: Accelerate Market Access to Europe with MIA License - Flyer

October 4, 2021

EU Market Access: Accelerate Market Access to Europe with MIA License

Reduce Launch Timeline and Improve Business Efficiency

Flyers Ensure Product Quality and Patient Safety With the Right Quality Management System (QMS) - Flyer

December 2, 2023

Ensure Product Quality and Patient Safety With the Right Quality Management System (QMS)

Save Time and Boost your Bottom Line

eBook Outsourcing of Medical Information Content Creation: Experience of 100 Clients eBook

October 17, 2021

Outsourcing of Medical Information Content Creation: Experience of 100 Clients

The time and effort required to write, review, edit, approve, maintain, distribute, and update Medical Information (MI) documents while retaining an auditable record of the search strategy is a great...

Whitepapers Good Science Presented Well Generates Approval - A ProPharma Whitepaper

October 14, 2021

Good Science Presented Well Generates Approval

Without good data, any application has little chance of success. Working with a regulatory consultant that has an excellent understanding of the science and how to present it properly is the surest...

Whitepapers How to Compile a Science-Backed New Drug Application (NDA) Submission Whitepaer

October 14, 2021

How to Compile a Science-Backed New Drug Application (NDA) Submission

Developing a successful NDA is critical to the success of your product and company. Learn how to develop a science-focused submission like an expert with these six tips. You are getting ready to...

Whitepapers A Guide for Efficacious Data Integrity During COVID-19 Whitepaper

October 14, 2021

A Guide for Efficacious Data Integrity During COVID-19

Learn how ProPharma implements data integrity measures to prevent reputation damage, unsafe products, and costs. With the current pandemic creating schedule delays, interrupting supply chains, and...

eBook Evolving EMEA MI Service Models eBook

October 14, 2021

Evolving EMEA MI Service Models

There are 116 countries in the EMEA region and around 24 languages spoken, how do you know what structure and model are best for each client and how do you go about making it happen? There are so...

Whitepapers Whitepaper: What You Need to Know About GxP Independent Compliance Audits

October 13, 2021

What You Need to Know About GxP Independent Compliance Audits

Simply having the appropriate standard operating procedures (SOPs) in place is not good enough; procedures must be followed to the letter. Prevent the consequences of quality systems being...

eBook Outsourcing Medical Information Services: When to Consider a Dedicated Resource eBook

October 4, 2021

Outsourcing Medical Information Services: When to Consider a Dedicated Resource

Outsourcing Medical Information (MI) services can be an effective solution for ensuring the provision of MI services to HCPs and consumers globally. The most cost-effective model for the provision of...

eBook Improving Product Quality During Technical Transfers eBook

October 4, 2021

Improving Product Quality During Technical Transfers

Is your product quality at risk during a tech transfer? Now, more than ever, companies are transferring products and processes from one site to another, often facing pressures on time, resources, and...

Guide 6 Key Elements of Successful Drug & Device Development in Europe

March 31, 2023

6 Key Elements of Successful Drug & Device Development in Europe

Challenges of Complying with EMEA and Country-specific Regulations Navigating EMEA and Country-specific regulations is both confusing and a mammoth task. The EU regulatory system has around 50...

Case Study CMC Program Management Case Study

March 24, 2023

CMC Program Management

Learn how a biotech company sought help from ProPharma for the CMC section of their CAR T-cell therapy program. An experienced CMC program management consultant developed and facilitated a product...

Case Study Drug Development Program Management Case Study

March 24, 2023

Drug Development Program Management

Discover how ProPharma assisted a biotech company who needed help with drug development program management, NDA and MAA filing for their immuno-oncology products. ProPharma provided an experienced...

Case Study Medical Affairs Case Study

March 24, 2023

Medical Affairs

Explore how ProPharma helped a large pharmaceutical company who needed more medical affairs leaders for scientific and project management expertise for their rapidly growing medical affairs...

Case Study Medical Safety Scientist Case Study

March 24, 2023

Medical Safety Scientist

This case study outlines the successful collaboration between a pharmaceutical company's medical safety department and an experienced ProPharma safety scientist who was able to handle a spike in...

Case Study Quality and Analytical Scientist Case Study

March 24, 2023

Quality and Analytical Scientist

Learn how ProPharma partnered with a pharmaceutical company who experienced a spike in demand for quality and analytical scientists, necessitating the need for an experienced consultant to take...

Case Study Regulatory Affairs Project Manager Case Study

March 24, 2023

Regulatory Affairs Project Manager

The regulatory affairs department of a biotech company faced a challenge in meeting regulatory filings for important company deadlines, and sought ProPharma’s help. As a result, the client was able...

Case Study SOPs and Processing Mapping Case Study

March 24, 2023

SOPs and Processing Mapping

This case study outlines how a biotech company struggling with compliance and a lack of standard operating procedures (SOPs) turned to ProPharma for help. The consultant recommended a process mapping...

Case Study Scalable FSP Model for Managing IVD Clinical Trials in a Niche Market Case Study

March 29, 2023

Scalable FSP Model for Managing IVD Clinical Trials in a Niche Market

Scaling resources for clinical trials can be a daunting task, especially when demands fluctuate over time. In this case study, a sponsor faced several challenges related to resource allocation and...

Guide Guide to 6 Things to Consider When Selecting a Research Platform

April 6, 2023

6 Things to Consider When Selecting a Research Platform

Unlocking the Full Potential of Your Life Science Organization: Investing in Digital Initiatives As a leader in the life sciences industry, we know that data is one of the most valuable assets for...

Whitepapers Improve Quality & Consistency by Leveraging AI for Trial Master File Classification

May 3, 2023

Improve Quality & Consistency by Leveraging AI for Trial Master File Classification

Improve Quality and Consistency by Leveraging AI for Trial Master File Classification The whitepaper "Improve Quality and Consistency by Leveraging AI for Trial Master File Classification" addresses...

Guide Guide: Maximizing Patient Outcomes. A Contact Center Needs Assessment

May 16, 2023

Maximizing Patient Outcomes. A Contact Center Needs Assessment.

Unlock the secrets to designing effective patient support programs with our invaluable guide. By embracing a patient-focused approach and utilizing our comprehensive contact center checklist, you can...

Whitepapers 5 Key Challenges in the Development of Cell & Gene Therapy

May 24, 2023

5 Key Challenges in the Development of Cell & Gene Therapy

Challenges in Cell and Gene Therapy Development Developing and bringing Cell and Gene Therapy (CAGT) products to market comes with significant challenges. This whitepaper focuses on the key obstacles...

Case Study FSP models for IVD Clinical Trials:  Meeting Growing Pipeline Demands Case Study

June 12, 2023

FSP models for IVD Clinical Trials: Meeting Growing Pipeline Demands

Streamlining Clinical Trial Operations: How the FSP Model Transformed a Mid-Sized Biotech Company's Success. In this case study, we delve into the experience of a mid-sized genetic testing and...

Flyers Functional Service Provider (FSP) Value Proposition Flyer

June 21, 2023

Functional Service Provider (FSP) Value Proposition

At ProPharma, we forge strategic partnerships with our clients to collaboratively devise optimal strategies and drive remarkable results and operational excellence. With our cutting-edge FSP...

Flyers Labeling Development & Intelligence

June 21, 2023

Labeling Development & Intelligence

Our cutting-edge labeling intelligence solution at ProPharma empowers our highly skilled labeling development consultants to offer an unmatched product development strategy and top-tier labeling...

Case Study Enhancing Site Capacity for Clinical Trials with DCT Nurses Case Study

June 27, 2023

Enhancing Site Capacity for Clinical Trials with DCT Nurses

Discover how ProPharma helped a US biotech company focused on rare neurologic conditions overcome challenges in securing qualified resources for their study sites. Our FSP solutions, featuring study...

Whitepapers Compliance Auditing: Diving into Common Critical Findings Whitepaper

July 31, 2023

Compliance Auditing: Diving into Common Critical Findings

Compliance Auditing: Diving into Common Critical Findings Discover the crucial role of compliance auditing in the healthcare industry with our in-depth whitepaper, now available for download. Our...

Case Study Biostatistics and Programming - More than Just Clinical Trials - A ProPharma Case Study

October 16, 2023

Biostatistics and Programming - More than Just Clinical Trials

Learn how ProPharma’s Biostatisticians and Programmers enabled a small biotech company to derive more meaningful and actionable insights from their legacy data.

Flyers Product Quality Complaint Management - ProPharma

October 19, 2023

Product Quality Complaint Management

Ensuring the safety and health of patients is of utmost significance when it comes to pharmaceuticals, medical devices, and diagnostic programs. This is especially vital in today's intricate and...

Case Study Case Study: Product Quality and Safety Issues with Global Collaboration

November 6, 2023

Tackling Product Quality and Safety Issues through Global Collaboration

See how ProPharma effectively addressed a globally renowned corporation's surge in product quality complaints and financial pressures by establishing a tiered support system, leveraging offshore...

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