We know the unique challenges clinical studies of maternal and pediatric populations present
We understand the physiological and ethical reasons for these challenges, and the diverse and discrete issues, and we are skilled in the nuances of this patient group. So our solutions in study design and implementation deliver high quality results acceptable to regulatory agencies and prominent journals.
Ravinder Anand, Ph.D.
Having a CRO with extensive experience specifically in the maternal health and pediatric domain can give you greater confidence in your clinical trials and resulting data and also ensures that your study
protocols, data, site monitoring plans, and statistical analyses are designed to address things such as:
- Compliance issues in adolescents
- Neonates hospitalized populations in tertiary care units
- Parental involvement
- Risks in adolescent psychiatric studies
- Recruitment issues associated with the scarcity of eligible patients
- Working with preverbal or nonverbal children, and so much more.
Services for Clinical Research in Maternal and Child Health
- Statistical leadership, reporting and analysis
- Development of study materials (protocol, ICF/Assent template, manual of procedures, study logs, CRFs, instruction manuals, training materials)
- Advantage clinical data platform featuring one unified platform for
- eCRF, ePRO, IWRS and IP Tracking
- Specimen and image tracking and management
- Site selection, management, monitoring and training
- Study administration and management
- Data management and bespoke data solutions
- Global regulatory support
- Customized apps for remote data capture
- Centralized cloud-based repository with expert review of images, biopsies, sonography, etc. including those maintained within a PACS system
Open communication between our therapeutic area leaders and your team is key to success. Get in touch to discuss your plan for maternal and/or pediatric trials and how we can support your development pathway.