CRO Services

Full-Service CRO

The path to project success begins with choosing the right model and methodology to anticipate and manage the challenges that could arise during the lifecycle of a clinical trial. In response to more stringent regulations, globalization, and ever-changing technologies, ProPharma can build and tailor the optimal operational model to support consistent quality delivery and maximize participant recruitment and retention while expanding access to diverse populations. We will work with you to develop strategic, flexible approaches that leverage technology, clinical informatics, and our global reach to maximize data‑driven decision making that drives safety, quality, and efficiency.

Clinical Operations Services

Clinical operations play a pivotal role in the successful execution of clinical research, encompassing the design, implementation, and management of Phase I to IV trials.

With the increasing complexity of clinical trials, driven by heightened regulatory guidelines, the pressure on clinical operations teams has intensified. While some organizations allocate considerable time and resources to this aspect, others opt to outsource their clinical trials to Contract Research Organizations (CROs) specializing in the specific field of research. These CROs offer comprehensive services, ensuring end-to-end support for the seamless execution of trials.

Our dedicated clinical operations team collaborates with you to optimize the design of your clinical trials, implement patient-centric approaches, and provide guidance throughout the entire clinical development lifecycle. Discover how our experts can assist you in the multi-phase development of your clinical operations.

Data Safety Monitoring Board

Data Safety Monitoring Board (DSMB) services provide you with improved workflows, compliance, and communication to ensure the safety and integrity of your clinical study data.

PhoPharma’s team of medical consultants provide the option of safety data review (i.e., individual case safety reports and/or aggregate summaries of data) by a physician with experience in pharmacovigilance. The review and consultation include an assessment of the data and its significance to the conduct of the study. Our team then provides a recommendation for any actions to be taken, including reporting of aggregate data to the FDA as an IND Safety Report, requesting review by the DSMB, and/or changes to the Investigator's Brochure, Informed Consent Form, or study protocol.

ProPharma's DSMB, medical monitoring, and physician teams support a wide variety of therapeutic areas and will meet your requirements and keep your study moving forward by providing any or all of the following services:

• DSMB program support
• Blinded and unblinded DSMB meeting support
• Eligibility requirements review for inclusion/exclusion criteria issues
• Protocol review for exemptions and deviations
• Medical crisis impact review involving a study patient
• Biostatistician review
• Laboratory findings review
• Reporting a serious adverse event (SAE)
• Causality assessment discussions
• Clinical Trial Emergency Unblinding Services

Medical Monitoring Services

At ProPharma, our medical monitoring consultants will work with you to ensure safety and compliance throughout your clinical trials, from pre-trial planning through end-of-trial review.

Our team of physicians can evaluate your medical monitoring system to ensure there are no pharmacovigilance medical monitoring bandwidth issues, and partner with you to ensure you have the right resources to keep your clinical trials on schedule.

We will help you meet requirements to maintain quality and compliance throughout your clinical trials. Our medical monitors have vast knowledge in a wide variety of therapeutic areas and partner with you to address all your needs, including:

• Inclusion/exclusion criteria issues
• Protocol exemptions and deviations
• Medical crisis monitoring for cases involving a study patient
• Medication issues
• Laboratory findings
• SAE reporting
• Causality assessment discussions

Contact us to learn more about our medical monitoring services and how we can provide expert guidance for your upcoming clinical trials.

Clinical Trials for Pharmaceuticals, Biologics, Medical Devices, and Diagnostics

With dedicated pharmaceutical, medical device, and diagnostics teams, ProPharma supports clinical trials in the most cutting-edge technologies, maintaining expertise in novel uses of less novel therapeutics, and repurposing products. We have internal SMEs including a Biologics Center of Excellence and create solutions to complex challenges.

Deep Functional Expertise

ProPharma’s Medical Writing teams create best-in-class quality documents to support all elements of your clinical trial needs, from protocol and consent forms, Investigator’s Brochures, clinical study reports, patient narratives, and CTD Module documents, to registering and disclosing clinical trial information on public registries and redacting documents to meet commercial transparency obligations while protecting patient and company confidentiality.

Our world-class Biostatistics and Data Management teams and programmers are adept at creating and managing quality design, build, and outputs. They will partner with you to ensure you achieve the most robust and successful outcomes, incorporating unique and adaptive designs where best suited.

Global pharmacovigilance specialists and medical monitors are here to support the safe implementation of your studies, and provide expert guidance, reporting, and DSMB management. We have a range of disease and therapy area experts to ensure you have the best, contemporary advice.

Site & Patient Services

ProPharma's Site & Patient Services act as a seamless extension of the site team, combining experienced staff, standardized processes, and enabling technology to deliver consistent, compliant support worldwide. This integrated approach accelerates start-up, speeds enrollment, improves retention, streamlines visits, and enhances the patient experience across traditional, hybrid, and decentralized clinical trials (DCTs).

By unifying site, patient, and operational support into one coordinated model, we reduce the administrative and logistical burdens that commonly slow studies. Our teams adapt to each protocol and region, support high‑impact activities such as pre‑screening, patient outreach, and home health visits, and ensure sites have the resources they need at every stage. This flexible framework helps sponsors improve efficiency, strengthen participant engagement, and maintain quality across any study design or trial setting.

Site Support

Our flexible resourcing and patient centric support solutions empower clinical sites with both onsite and remote staffing options tailored to the unique needs of each study. We provide highly qualified professionals – including Study Coordinators, Research Assistants, and specialized roles such as Dieticians, Data Managers, and more – allowing sites to expand capacity by supplementing existing teams with the right expertise at the right time. Through customized support models designed for traditional, hybrid, decentralized (DCT), and fully virtual clinical trials, we enhance patient centricity by improving engagement, compliance, and retention.  

Backed by ProPharma’s global network of clinical research professionals, our scalable approach ensures sites receive reliable, high quality support that strengthens operational efficiency and elevates the overall patient and site experience. Our team can support your sites at every step of the study process starting from patient recruitment and pre-screening to data entry and visit reminders, we help sites stay focused on what counts – delivering exceptional patient care and driving study success. 

Home Visits

It can be overwhelming to determine how to deploy a patient-centric approach, so incorporating home visits into your protocol is often a great place to start. ProPharma can support home visits as part of a hybrid or fully virtual trial design. Home visits allow for greater flexibility in your study design and reduce the burden of participation by creating processes that fit into the patient’s life, rather than asking the patient to fit their life into the trial. Allowing simple procedures to be performed in the patient’s home also reduces the burden on the site by enabling site staff to focus on recruiting, enrolling patients, and managing more complex procedures. 

Home Visit Procedures

Our visit capabilities include critical procedures that support your clinical trial’s success. Let our team of experts review your protocol or draft synopsis and consult with your team on which visits or study activities could benefit from a Site & Patient Services model. Our procedural capabilities are as follows: 

• Vital Signs and Associated Variables
  • Temperature
  • Respirations
  • Blood Pressure
  • Pulse/Pulse Oximetry
  • Weight/Height/BMI
• Lab Sample Collection and Processing
  • Blood/Plasma
  • Urine
  • Saliva/Sputum
  • Stool
  • Finger Sticks
• IP Logistics
• Targeted Clinical Assessments
• IP Administration
  • Infusion
  • Injection
  • Oral
  • Topical
• Telehealth Support
• Patient-Reported Outcomes and Scales
• Patient Training
  • IP Administration
  • Diary Completion
  • Device or Wearables
• Other Safety Assessments
  • Changes in Health Status or Concomitant Medications
  • ECG Collection

Streamlined Technology

Our comprehensive clinical research platform integrates a robust Clinical Trial Management System (CTMS) designed for seamless site activity tracking, ensuring real-time visibility into study progress and operational performance. With built-in eSource, eConsent, and Telehealth capabilities, the platform fully supports remote and hybrid clinical trials, enabling participants and site support staff to engage virtually while maintaining data integrity and regulatory compliance. By streamlining workflows and automating routine tasks, the solution significantly reduces administrative burden for both sites and sponsors—ultimately enhancing efficiency, improving patient experience, and empowering research teams to focus on high-value clinical activities. 

Embedded Solutions

Our team of project leaders and clinical subject matter practitioners can support you in your journey to successfully deliver projects, achieve critical outcomes, and realize or improve efficiencies. Whether you are looking for an expert to provide advisory services or several cross-disciplinary personnel our solutions-focused approach will add value to your organization.

In-Depth Expertise

Our team of clinical experts bring leadership to your projects to help you successfully complete your important, complex projects regardless of where your team is in the clinical development process. We help you get to decisions quickly and achieve outcomes.

Global Medical Writing Transparency

ProPharma strategically partners with clients to provide individualized, single-source, scalable medical writing solutions across the following areas:

• Medical Writing – Clinical, Nonclinical, Device, Diagnostics, and Publications
• Quality Control Review and Editing
• Clinical Trials Disclosure – Document Redaction/Anonymization, Clinical Trial Registry Authoring, Plain Language Authoring, and Management Consultation
• Project Support – Project Management, Document Publishing, Submission Management, SOP Development/Template Creation

Our global team of medical writers and reviewers have deep domain expertise and autonomously drive projects to completion, collaborating with cross-functional teams to coordinate all aspects of input, production, and review of every document with a laser focus on quality. Whether you need to outsource all medical writing across several clinical trials or a portfolio of products, or you need project-based support for individual medical writing deliverables, our expertise and experience can be leveraged to build a customized solution that achieves all your project goals.