Our Solutions

No clinical study is perfect​. Every clinical study is at risk of encountering challenges at some point. We contend with these challenges by understanding that every solution must be as unique as the challenges they seek to address. From developing the Clinical Study Protocol, managing/reviewing the eTMF throughout the study, to drafting the Clinical Study Report, Modoc can help assure compliance of your study or project with regulations, guidelines, and SOPs.

Quality Assessment

Modoc understands the importance of your clinical development program. How a company conducts and manages their clinical studies in compliance with SOPs and regulations/guidelines is a direct reflection of their commitment to quality data.

Whether you are executing a clinical study with in-house personnel, outsourcing it to a large CRO and/or other vendors, or a combination of these, Modoc can provide an independent assessment of your study and the documentation that the regulatory authorities will review when evaluating your regulatory filing.

Quality Assessments can include: Review of SOPs, clinical operational plans, trial master files (paper and/or electronic), training documentation, vendor oversight, computer system validation, and overall pre-approval inspection (PAI) readiness.

Medical Writing

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

We have experience writing documents for all study phases and study designs, including the following document types:

  • Protocols and protocol amendments
  • Investigator Brochures
  • Informed Consent Forms
  • Study Procedures Manuals
  • Study Procedures Manuals
  • FDA briefing documents
  • Narratives (safety and CSR)
  • Clinical Study Reports (CSR)
  • Standard Operating Procedures (SOPs)

Electronic Trial Master File (eTMF) Services

The use of eTMFs is increasing as technology assumes a greater role in clinical studies. But, our reviews of eTMFs for both completed and in-process clinical studies indicate that most eTMFs for individual studies are not compliant with regulatory expectations regarding eTMFs, and do not fulfill the essential function of “telling the story of the execution of the clinical study”.

  • Review of existing eTMFs:
    • Quality Assurance audit of a sampling of artifacts, to identify any significant issues or trends
    • 100% Quality Control review of entire eTMF or identified Zones or sites, to identify specific issues to be corrected
  • Management of projects to correct identified eTMF issues, including identified issue tracking, verification of corrected issues, and project metrics
  • Management of eTMFs
    • Populating artifacts in your eTMF system upon receipt from functional personnel/CRO personnel
    • Periodic Quality Control review of the eTMF, either calendar-based or milestone/event-based

Electronic Investigator Site File (eISF) Product and Services

Investigator sites dedicate significant personnel time and office space to maintaining paper ISFs. Modoc offers an electronic ISF solution (eISF), backed by Modoc’s extensive industry experience.

eISF Solution includes:

  • configuration compliant with the DIA TMF Reference Model 3.0 taxonomy and ICH E6R2
  • security enhanced with role-based user privileges for site personnel and sponsor/CRO representatives
  • validated
  • collaborative space for site and sponsor/CRO personnel, including across network sites
  • use to manage site SOPs, training records, etc.
  • priced suitably for inclusion in study budgets

eISF Services include:

  • training
  • administration, or training of administrator(s) with provided SOPs
  • Certified Copy (per ICH E6R2) SOP template
  • periodic (milestone- or calendar-based) QC review
  • document management and training file management consulting

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

Our Expertise