Expertise
ClinScript writers are all degree-trained scientists and skilled in preparing documentation for any therapeutic area and indication. We write for a global clientele, from small biotech companies to multinational pharmaceutical companies and clinical research organizations (CROs). Our expertise comes from years of experience working in all phases of clinical development, which brings the depth of understanding needed to effectively communicate specific messages for varied documents.
Therapeutic Area
We have written hundreds of documents in the following therapeutic areas and can bring the benefits of this extensive experience to your particular indication:
• Oncology
• Immunology
• Hematology
• Endocrinology/Metabolism
• Cardiology
• Pediatrics
• Neurodegenerative diseases
• Respiratory/Pulmonary
• Skeletal disease
• Rheumatology/Arthritis
• Anti-infectives
• Urology
• Ophthalmology
• Vaccines
ICH-GCP
ClinScript writers are fully conversant with International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) standards as well as European, US, and other local regulatory requirements and all our documentation complies with these standards.
Regulatory Submissions
ClinScript LLC has extensive experience in preparing clinical documents and Common Technical Document (CTD) submissions. Regulatory documentation is our focus. Each dedicated team at ClinScript has more than 15 years of cumulative experience writing clinical documentation for the global pharmaceutical industry. We have written hundreds of Clinical Study Reports for all phases of clinical development and most indications. We have planned and prepared dozens of CTD submissions, from straightforward local variations to complex global submission dossiers for multiple indications.