Modoc’s team of experienced medical writers has the skills, knowledge and experience to deliver a wide range of clinical trial documents to support your specific study. We know how important it is that each study has well-written documentation that provides all relevant information needed for the successful implementation of the study. Every protocol and associated study documents are developed in collaboration with the client sponsor to ensure that all sponsor requirements and objectives are addressed as well as providing user-friendly, clear, and concise documents.
Our writing experience includes, but is not limited to:
- Protocols and amendments
- Informed consent documents
- Study procedures manual
- Reporting and Analysis Plans
- SAE Narratives
- Clinical Study Reports
- Clinical Trial Registry reports
- IND/NDA submission summaries
- Abstracts, manuscripts, journal articles and posters
Our writing types and designs include, but are not limited to:
- Adaptive study designs
- Phase I and II studies
- First Time in Human studies
- Dose-Escalation studies
- Combination/comparator therapy
- Hepatic and renal impairment studies
- Food-Effect studies
- Pharmacokinetic/pharmacodynamic (PK/PD) studies
- Drug-Drug Interaction studies
- Cardiotoxicity (QTc) studies
- ADME studies
- Bioequivalence and Bioavailability studies
Our manuscripts and abstracts have been written for submission to:
- Journal of Clinical Pharmacology
- British Journal of Clinical Pharmacology
- Investigational New Drug Journal
- American Association of Clinical Research
- Blood – Journal of American Society of Hematology
- Journal of Hematology and Oncology
- Journal of Clinical Oncology – American Society of Clinical Oncology
- Journal of Thoracic Oncology