GreenLight Clinicals’ preclinical teams can assist you in selecting, adapting and executing developmental programs in both non-GLP and GLP settings. Backed up by years of laboratory experience, we have a broad understanding and global network to access the models you need.
Our team of biostatisticians, subject matter experts and regulatory affairs specialists work together to ensure your endpoints are statistically relevant, meet reduction/replacement/refinement standards and provide outcomes that fit with global regulatory requirements.
We provide a full statistical support service from study design, endpoint selection, analysis and output to our clients. We produce data in all standard formats for global regulatory filings and submissions, using industry standard statistical software.
Preclinical Study Reporting
Our in-house team of Medical Writers works closely with our preclinical and biostatistics team to produce preclinical study reporting for all stages of product development. We routinely integrate these outputs with clinical development plans, product dossiers, investigator’s brochures and clinical research protocols.
Scientific Writing & Manuscript Support
Our team of scientific and laboratory research experts have been involved in over 500 scientific manuscripts in high-impact journals across their basic and commercial research careers. From conference abstract, poster and presentation support, to manuscript development & drafting, table and figure development and support for literature collation and review, we offer a full-spectrum scientific writing service to our clients.
Ethics & Regulatory Support
GreenLight Clinicals’ preclinical teams routinely support our clients in the organisation, collation, and reporting of ethics applications to both academic and government institutions and global regulatory agencies, helping you to expedite submissions at the highest quality standards.