We can lead projects from start to finish for certain study designs and sponsor types. We have unique experience in biotech, pharma, interventional, observational data, and large-scale biospecimen collection studies.

Our expert biostatisticians apply scientific principles and therapeutic indication knowledge to support you throughout clinical development. Biostatistics is at the heart of every clinical study—driving study design, study conduct, data collection, analysis, and reporting—and our biostatisticians work closely with the entire project team throughout the study to ensure that the correct data is captured and ready for analysis.

Medical writers are critical to the communication process of outlining the goals, strategies, analysis, and medical understanding of a clinical trial/program to patients, sites, sponsors, and regulatory agencies. Our scientific-minded writing team has significant experience preparing clinical documents, including protocols, clinical study reports (CSRs), and Investigator's Brochures.

We have created a Standard Operating Procedures (SOPs) library to establish and ensure consistent compliance with Good Clinical Practice guidelines. These SOPs apply to all types of federal regulations common to clinical research. Standardizing these SOPs aligns with our clinical research activities across your organization.

Our protocols are always developed collaboratively, with each undergoing full verification through the operational components of the organization. We only recommend a protocol or proposed program with complete knowledge of the logistical and financial implications, as well as the clinical and regulatory implications.

Our medical experts participate in planning and implementing clinical programs to plan for and mitigate patient safety risks while increasing data quality.

Our clinical operations team is highly skilled professionals who drive the project management, project administration, patient recruitment, patient retention and clinical monitoring, and site management functions for your clinical trials.

Whether you are at the beginning of your development program and need to prepare your regulatory strategy, are meeting with the agency preparing to file your IND/CTA, are entering your pivotal Phase 3 studies and need to discuss with the regulatory agency, or are preparing to submit a marketing application - our regulatory experts can help.

Successful clinical trial management pivots around the project manager - our strategic, pro-active thinkers manage the study timeline, plan for risk mitigation and overcome challenges.

Our highly qualified scientific-minded strategists provide you with the knowledge, foresight, and expertise to make informed strategic decisions to accelerate your medical therapies along the drug development pathway. We guide your decision-making before, during, and after your clinical trials are complete.

Statistical Programming provides various services to understand a test product's effect on safety, efficacy, or other points of interest. Programming works closely with our Biostatistics team to carry out planned analyses, including creating and QC analysis datasets and tables, listings, and figures (TLFs).