Areas of Expertise

Here are the service areas BioBridges' clinical experts can help you bridge the gap between your life's work and a healthier world.

BioStatistics Consulting icon

BioStatistics Consulting

Biostatistics is responsible for the development of statistical analysis plans for clinical studies and proper interpretation of scientific data generated from clinical studies.

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Clinical Operations Consulting icon

Clinical Operations Consulting

Clinical Operations, or Clinical Trial Development, is responsible for the management and oversight of clinical studies with direct oversight of vendors, clinical sites, and clinical research organizations (CROs).

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Data Management Consulting icon

Data Management Consulting

Clinical Data Management (CDM) is a critical aspect of clinical research, which leads to the generation of high-quality, reliable, and statistically sound data from clinical trials.

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Medical Affairs Consulting icon

Medical Affairs Consulting

Medical Affairs is responsible for developing, managing, and optimizing the lifecycle of a product after it has been approved. These functions include managing key relationships with healthcare professionals (HCPs), organizing and overseeing the publication of data from clinical studies, presenting educational information about a product, disease state, answering HCP questions and supporting research initiatives outside labeled indications for marketed products.

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Oversight Consulting icon

Oversight Consulting

Medical directors are key to drug development teams and are responsible for clinical program leadership, clinical study development, oversight, monitoring, and reporting. This function can have input into initial study design, protocol, development, full study execution, or select medical task assistance.

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Scientific & Medical Writing Services icon

Scientific & Medical Writing Services

Medical Writing is responsible for developing documents that effectively and clearly describe clinical study plans (protocols), study results (study reports), product use, and other medical information.

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Non-Clinical icon


Non-clinical is responsible for estimating and optimizing the safe dose for the first-in-human study and predicting a product’s safety profile.

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Program Management icon

Program Management

Program Management is responsible for advancing an experimental product across functions, from research to development to commercialization.

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Medical Quality Assurance Consulting icon

Medical Quality Assurance Consulting

Quality Assurance assures that products have appropriate characteristics of “safety, identity, strength, quality, and purity.”

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Regulatory Affairs Consulting icon

Regulatory Affairs Consulting

Our Regulatory Affairs consultants ensure that your company complies with relevant regulations and laws, liaises with regulatory agencies (such as FDA) and internal teams on specific issues pertaining to drug/device development, and leads cross-functional teams to develop regulatory submissions (IND, NDA, etc.)

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Pharmacovigilance Consulting icon

Pharmacovigilance Consulting

Drug safety, also known as pharmacovigilance (PV), is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical or device products. Ultimately, drug safety is concerned with identifying the hazards associated with pharmaceutical products and with minimizing the risk of any harm that may come to patients.

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