Boston Strategic Partners

Boston Strategic Partners

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Clinical/Contract Research Organization (CRO) Services

Advance Your Clinical Trials With Expert CRO Services

BSP offers a range of CRO services under the Functional Service Provider (FSP) model to help bring your products to market efficiently and in compliance with regulatory requirements. Our experienced experts in medical affairs, clinical development, statistics, and regulatory domains provide tailored support for your clinical trials across all phases.

BSP’s Comprehensive Clinical Trial Solutions

BSP offers a comprehensive range of services covering every stage of your clinical trial journey, from pre-trial planning through to post-marketing studies, including ad-hoc analyses

Our expertise spans:
Drugs
Biologics
Diagnostics
Medical Devices
– across diverse therapeutic and disease areas

BSP offers tailored expertise across all phases of clinical development

Clinical Trial Planning

  • Expert study design consulting to optimize your clinical trials, ensuring they meet scientific, regulatory, statistical, and IRB/ethical standards
  • Comprehensive statistical analysis plans tailored to your study objectives

Site selection

  • Identification of sites and their prioritization to ensure that each prioritized site has the capacity and human capital to execute trial efficiently, based on well tested set of criteria
  • Ensuring accreditations, infrastructure, and other ancillary services are available
  • Providing timely updates of site performance on a dynamic dashboard, and advice on course correction as needed

Compliance and Regulatory Consulting

  • Assistance with submissions to regulatory agencies
  • Ensuring adherence to regulatory requirements and guidance for submissions to agencies like the FDA, EMA, and others
  • Regulatory submission package development, F2F meetings, and other required written communication with regulatory authorities

Project Management

  • Monitoring of clinical trial progress and compliance with protocols, including Trial Master File (TMF) management
  • Coordinating and overseeing all aspects of the clinical trial process to ensure timelines and budgets are met

Data Management and Statistical Analysis

  • Collection, processing, and management of clinical trial data
  • Analysis of clinical trial data and interpretation of results by experienced biostatisticians
  • Advanced statistical modeling and production of high-quality tables, listings, and figures

Medical Writing

  • Preparing study protocols, clinical study reports, regulatory submissions, and scientific publications

Quality Assurance

  • Conducting audits to ensure compliance with regulatory requirements and industry standards

We also provide an end-to-end solution by working with our CRO partners for screening, recruitment, study start-up, data collection, etc.

Unlock the full potential of your clinical trials with our professional CRO services

Please reach out to us for a consultation or to learn more about how to streamline your path to market success

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