Clinical Data Management
From generation of data-point till Database Lock, our FSP resources provide customized,
innovative data management solutions.
Our data management methods help you to ensure.
Traceability of data 
Data transparency Data quality Reduce oversight
Statistical Programming
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.
Our experienced programmers are capable of deliver below deliverables
without any guidance SDTM’s, ADaM’s, TLF’s, RMP Analysis,
DSUR, PSUR, Submission packages such as Define, Legacy to CDISC conversions and many more.
Biostatistics
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.
Key areas of our expertise
- Drafting Concept Sheet
- Drafting Protocol (Statistical Section)
- Sample Size Calculations
- Statistical Analysis Plan
- Mock Shells review
- Coordinate Interim analysis
- Review CSR outputs
Medical Writing
We provide world-class medical writing expertise across a broad range of
therapeutic areas and document types, from preclinical reporting through the
drug development life cycle to post-marketing and commercialization writing.
Key areas of expertise
- Protocols and amendments.
- Investigational medicinal product dossiers (IMPDs)
- Informed consent forms and patient information leaflets.
- Clinical study reports (full, abbreviated, interim, and synoptic)
- Patient-level and event-level safety narratives.
Clinical Operations
We provide leadership excellence and operational expertise through collaborative planning, implementation, and execution. Clinical research associates work closely with your team on protocol and indication training, building strong site relationships, and ensuring site compliant with health authority regulations.
Key areas of our expertise
- 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.
- Training of clinical research associates.
- CRA management and quality control.
Medical Affairs
Our Medical Affairs experts are the face of the sponsor and their scientific and clinical expertise
helps them facilitate the flow of information between the medical community and the organization
Key areas of expertise
- Helping the brand team in formulating scientific strategy.
- Reviewing the clinical trial proposals submitted by independent investigators and determine if the outcomes merit financial support for the study.
- Defining a publication plan for each product and coordinating clinical/scientific communication at medical congresses.
- Cultivating relationships with Key Opinion Leaders (e.g., healthcare practitioners, academic researchers, experts in defined therapeutic areas).
Project Management
Our team oversee the cross-functional activities required to develop and commercialize client’s products in alignment with the R&D governance processes. Our project management solutions provide dedicated support from Early Phase to Phase IV, and expert Project Managers for safety and pharmacovigilance portfolio work, delivering consistency across programs and submissions, and covering all therapeutic areas and indications.
Key areas of our expertise
- Works in partnership with drug development project leaders to develop, gain approval, and execute on the project strategy.
- Co-chairs timely, efficient, and action-oriented Development Project Team meetings and is responsible for coordinating team operations and communications.
- Directs highly complex project communications and ensures that all project customers are fully informed and knowledgeable of project activities and their status.
- Organizes preparation of high-quality documents for review by governance committees in collaboration with the project team and represents the Development Project Team at Governance meetings, when needed.
- Organizes Project Management support for various functional areas on the Project; attends sub-team meetings; organizes ad hoc working groups.
- Organizes the formation of Project Teams and Request for Development (RFD) Teams with leadership of the functional areas, and guides transition of projects between development phases.
Resourcing Process
We provide fully screened applicants which includes steps for education and employment verification, background checks, reference checks, comprehensive skills assessments.
Resources with
a strong track record.
screening
screening
checks
