Clinical Data Management Services

Clinical Data Management Services

SPsoftIndia is providing clinical data management services in india via SPLIFE service.Our expertise ranges from clinical-regulatory documents required to support clinical study protocols /amendments, investigator brochures, product labeling, ICDs, and clinical study reports and patient narratives, authoring of eCTDs, etc.

We additionally offer wider-scope writing services including authoring of manuscripts and other post-marketing documents.The regulatory documents includes :-

• Paediatric investigation plans.
• Standard operating procedures.
• Clinical study reports.