Our Solutions

No trial is perfect. Every project is at risk of encountering barriers or obstacles at some point. This is as true with our industry as it is with life in general. We contend with these challenges by understanding that every solution must be as unique as the challenges they seek to address.

Program Assessment

Modoc understands the importance of your clinical development program. How a company conducts and manages their clinical trials in compliance with standard operating procedures and regulations/guidelines is a direct reflection of their commitment to quality data. That's why we always start with a Program Assessment to address operational gaps, make process improvements, increase clinical trial quality and data integrity, and improve efficiency.

Program Assessment includes: Review of SOPs, operational plans, trial master files (paper and/or electronic), training documentation, vendor oversight, computer system validation, and overall inspection readiness.

Clinical Management

Whether at a program, project or study level, cohesive Project and Study management is essential to a project’s success and requires the supervision of many moving parts. This is why we focus on superior communication, adaptability and proactive planning from start to finish.

Services include​: Project management, feasibility assessments, IRB selection, clinical study contract and budget negotiation, regulatory document processing, pharmacovigilance oversight, site recruitment, qualification, selection and training, investigator meeting coordination, subject recruitment strategy and vendor selection.

Clinical Monitoring

We have built a large network of extremely experienced CRAs, and we pride ourselves in knowing the individual strengths and weaknesses of all. This allows us to make adept decisions about assembling the right people for your trial.

CRA responsibilities include​: Pre-Study Feasibility / Qualification Visits, Site initiation, Interim & Close-Out Visits, Regulatory compliance support & review, in-house & on-site monitoring, risk based monitoring, protocol deviation & violation corrective action plans, remote data quality review, drug accountability, and Query Management.

Medical Writing

Accurate documentation is integral in supporting the progress and results achieved in any study. Our medical writers are experienced and possess the vital skills, knowledge and expertise to provide the documentation that your specific study requires.

Our writing experience and writing types/designs are expansive, including (but not limited to)​: protocols and amendments, study procedure manuals, clinical study reports, safety narratives, FDA briefing documents, Bioequivalence/Bioavailability studies and other clinical pharmacology studies, and more.

We are confident in our process. Because while we may take the same steps, we always arrive at a custom plan or solution tailored to your needs.

Our Expertise