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CRO Services
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Clinical Trial Management

Selected and overseen by our Director of Clinical Operations, our Clinical Study Managers (CSM) serve as the main point of contact for our clients.

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Each of these individuals brings years of industry
knowledge and experience to the client study team

Field Monitoring/Clinical Research Associates

Realizing that each study is unique and requires an individualized clinical monitoring plan, we use a hybrid approach of therapeutic alignment and regionally based Clinical Research Associates (CRAs) to build the best monitoring team for each study.

Clinical and Regulatory Staffing

We hire only experienced, seasoned monitors who are trained on the protocol, standard operating procedures, applicable FDA guidelines and Good Clinical Practice

Protocol Development

Our highly esteemed Director of Clinical Development is active in all aspects of study trial protocol design, site and patient recruitment and sponsor communication

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Clinical Operations

Abbreviated New Drug Application, Common Technical Document, Investigational Device Exemption/Premarket Approval

  • Clinical Monitoring

  • Protocol Design

  • Site Selection

  • Clinical Study Management

  • Site Identification and Feasibility

  • Medical Writing

  • Vendor Management

  • Drug Safety Management

  • Regulatory Services

  • Assist and Guide in Designing and Conducting a Clinical Trial

  • Project feasibility evaluation

  • Regulatory Authorities Liaison

  • Document preparation and submission, e.g., Investigational New Drug, New Drug Application,

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Regulatory Compliance

Led by our extraordinary Director of Regulatory Affairs, our team provides every project with an individualized project feasibility evaluation, followed by personal guidance in designing and conducting a clinical trial.

 

We work with you to plan, prepare and complete all of your regulatory submissions and then act as your
liaison in all interactions with regulatory agencies

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Medical Monitoring

The medical monitor provides support to sites by addressing Investigator questions regarding appropriate interpretation/ application of the study protocol and advising regarding appropriate medical management of subject emergencies.

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  • Providing clinical development plans and protocol design input

  • Training staff and investigators

  • Serving as medical director to Sponsors without medical staff

  • 24/7 medical monitor coverage

  • Enhancement of regulatory compliance

  • Clarifying inclusion/exclusion criteria with the investigator

  • Providing consultation for potential safety issues or medical concerns regarding the clinical study

  • Medical review of serious adverse events

  • Providing medical review of Pristine Clinical Research deliverables such as final narratives or Clinical Study Reports

  • Organizing investigator meetings

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