What We Offer
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.
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).
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.
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.
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.
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.
Non-Clinical
Non-clinical is responsible for estimating and optimizing the safe dose for the first-in-human study and predicting a product’s safety profile.
Program Management
Program Management is responsible for advancing an experimental product across functions, from research to development to commercialization.
Medical Quality Assurance Consulting
Quality Assurance assures that products have appropriate characteristics of “safety, identity, strength, quality, and purity.”
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.)
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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2611 S CLARK STREET,SUITE 600, Arlington VA 22202, USA
info@asfsystemsinc.com
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