We work closely with our clients and participate in their successful completion of the initiatives. Our clients can depend on our services to achieve their outcomes by continuously understanding the dynamics of the ecosystem and staying focused on outcomes. Our ability to scale quality and customer focus, ensures that outcomes are positive and as designed.
Our Best Services
Study start-up including site identification, qualification, and selection.
Study document development.
Essential document collection and maintenance.
Trial Master File set-up and maintenance.
Site monitoring and management.
Patient recruitment and retention strategies.
Clinical trial management system.
CRA management and quality control.
Our Statisticians support all phases of clinical trial start from protocol development to CSR and also involved in agile trends in clinical Statistics such as Adaptive design, innovative way to represent data by avoiding redundant analysis.
Data Management Data
Biostatistics & Programming
Data Management Accreditation
Informed consent forms and patient information leaflets.
Clinical study reports (full, abbreviated, interim, and synoptic)
Protocols and amendments.
Investigational medicinal product dossiers (IMPDs)
Patient-level and event-level safety narratives
Cultivating relationships with Key Opinion Leaders (e.g., healthcare practitioners, academic researchers, experts in defined therapeutic areas).
Formulating scientific strategy.
Reviewing the clinical trial proposals.
Defining a publication plan for each product.
Process Improvement & Change Management
Our process standardisation is followed in four major steps, that are Productivity, Quality, Time and Cost.
Process Agility assessment and recommendations
Implement Process Change and alignment
Expedited & Periodic Reporting QPPV Office Support & Consulting.
Working from CRF review to till submissions, our statistical programmers are experts in regulatory guidance (CDISC standards) and provide the right level of expertise and experience to ensure quality project deliverables.
E Submission Authoring Tool are - 1 Product, 1 Country, 1 Sequence
Management of Submission Activity.
Variants for Other Countries.
Variants for Other Dosage/ Form/ Indication.
Management of the Submissions for all Portfolios.
Selection of Resources with a strong track record.
Thorough phone screening.