Contract Research Services

Your Drug and Device Development Partner

As a contract research solutions company we focus on improving the management of product development from the bottom up in order to save money and time. The result is a more efficient and affordable program that enables your team to create "lean" development program that minimize data integration, reduce project startup costs, and empower stakeholders to make informed data-driven decisions.

Whether it is augmenting internal staff with a functional outsourcing approach, or managing the program from beginning to end, we can do it, and do it more efficiently.

Frictionless Services


The right mix makes all the difference. We can provide you any or all of the following:

Biostatistics

Our extensive biostatistics services are tailored to meet your individual research needs. Led by a world-class statistician with more than 30 years of clinical trial experience, all Clinipace Worldwide statisticians have advanced degrees and work very closing with sponsor scientists and study managers to develop a comprehensive statistical analysis plan, including:

  • Statistical support for study design
  • Consult on randomization methodology
  • Detailed statistical analysis
  • Reporting
  • Production of tables, listings & figures
  • Support for manuscripts & abstracts

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Clinical Monitoring and Site Management

Our technology-driven clinical monitoring services are tailored to each client, based on the study protocol and client objectives. These solutions are available in whatever configuration meets your needs, and our TEMPO software platform provides piece of mind with always on, real-time study status. Using TEMPO each CRA will manage Central and Site Monitoring objectives including:

  • Ensure signed informed consent forms
  • Source Data Verification (SDV)
  • Review all eCRFs and discuss trends with site staff
  • Evaluate eCRFs for serious adverse events
  • Perform drug accountability
  • Review investigator study files for completeness
  • Ensure protocol compliance
  • Train, encourage and support sites

Additionally, Clinipace Worldwide will ensure regulatory compliance by managing site logistics, documentation, reporting, and payment. Our specialists will conduct feasibility assessments, prepare and manage study start-up documentation and site file notebooks, IRB preparation administration, and communication, regulatory file review, site payment, site status reporting, and site close-out tasks.

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Data Management

TEMPO™ – an integrated clinical data capture and study management software platform – is the foundation of our data management program. TEMPO's software-as-a-service model means project stakeholders can view their study's progress anyplace and anytime, and make informed real-time decisions regarding their research.

Together with TEMPO™, Clinipace Worldwide offers data management services that ensure clean, accessible, quality data. Data Management Services are designed to ensure:

  • Data validation and cleansing
  • Quality assurance
  • Database auditing
  • Data reconciliation
  • Export Management

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GxP/CMC Quality Assurance Consulting

The Clinipace Worldwide Regulatory and Strategy Development (RSD) team provides expert quality assurance services to pharmaceutical, biotechnology, medical device, and dietary supplement companies. Whether you are looking to develop and implement quality systems from scratch, or need to standardize and review the compliance of your existing systems, or your contractors’ systems, Clinipace Worldwide QA’s experienced team of auditors and QA professionals can help you.

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Medical Management/Monitoring

Medical monitoring by a licensed physician is an essential function to ensure the safety of trial subjects and the clinical integrity of trial results. Our medical monitors possess substantial experience in all phases of clinical trials from protocol development to SAE reporting to regulatory submissions. You can be assured that your study will be conducted according to protocol, that your study subjects will be carefully monitored and that you will have immediate visibility into any potential issues or concerns.

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Medical Writing

Clinipace Worldwide medical writers produce documents for all stages of clinical development including literature summaries, pre-FDA meeting briefings, regulatory filings, protocol development, Common Technical Documents (CTDs), case report forms, clinical study reports, , investigator brochures and annual updates, informed consent forms, and IRB communications, DSMB reports, and scientific abstracts, manuscripts, and journal articles.

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Patient Recruitment

The integrated Clinipace Worldwide approach to subject recruitment promotes subject trust and understanding by delivering recruitment messages in multiple ways with both the appropriate frequency and consistency.

Through ongoing client communications and technology-based approach, Clinipace Worldwide can identify trends and respond in near real time to fluctuations in media inventory, media saturation, and site enrollment performance. Working together, Clinipace Worldwide and our Clients will develop a media plan and creative content that best meets the project enrollment goals. Our creative team will work with you to understand your study objectives and create messaging strategies and programs that include broadcast and print advertising, online campaigns, printed/digital study material, direct response mailings, and public relations.

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PK/PD

Clinipace offers human pharmacology services that include, but are not limited to, single- and multiple-dose pharmacokinetic (PK) studies, bioavailability studies, bioequivalence studies, drug-drug interaction studies (DDI), population PK, and PK/PD or dose-response studies.

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Project Management

By applying proven clinical project management principles, Clinipace Worldwide project managers effectively manage and achieve milestones, meet project timelines, and optimize resources and communication pathways.

With every project, Clinipace Worldwide appoints an experienced project manager whose background and skills best match the project requirements, and along with an executive sponsor, serves as a liaison to all project stakeholders. With a commitment to open and transparent communication our project managers provide:

  • GCP adherence
  • Project visibility and lifecycle management
  • Comprehensive project and communication plan
  • Collaborate with sponsor to create data management, monitoring, and site management plans
  • Service & software coordination
  • EDC best practices
  • Investigator and site training


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Regulatory affairs and operations

The Clinipace Worldwide Regulatory and Strategy Development (RSD) team has vast experience in all facets of industry. This team has expertise in both pre and post-marketing drug safety regulations, document management, regulatory filings, global marketing authorization applications, variations and renewals and carefully developed due diligence strategies.

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Safety Surveillance

Clinipace Worldwide can provide you access to the tools and experience to provide a fully compliant and comprehensive drug/device safety program, and a wide array of safety services. From clinical trials safety to post-marketing surveillance, Clinipace Worldwide manages data collection, DSMB administration, triage, tracking, and reporting of your adverse events from start to finish.

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Site Selection and Global Study Feasibility

Clinipace Worldwide utilizes several approaches in identifying qualified sites and investigators. We consider the site’s location, staffing, qualifications, history, clinical trial experience, area of therapeutic experience, GCP/ICH compliance and patient population/enrollment history. We collaborate with you to select sites that will successfully meet your project needs.

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Strategic Product Development

The Clinipace Worldwide Regulatory and Strategy Development (RSD) team helps clients move their products from the lab to market while containing costs, reducing time and minimizing risks. We construct a detailed strategic plan along with a budgetary analysis so your projects stay on track and your investors are well-informed.

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