Clinical Operations
Our clinical operations adhere to ICH GCP regulations across all phases and are managed by our dedicated team of both regional and in-house clinical professionals. Our in-house eTMF and CTMS tools support our project managers and clinical operations teams to seamlessly manage sites and documentation. And we provide end-to-end support, encompassing everything from project management to patient recruitment to site closure, ensuring the success of your research.
Our services include:
Project Management- Vendor Management
- Site Identification and Selection
- IRB/EC Submissions and Approvals
- Site Initiation
- Monitoring (Both Onsite and Remote)
- Risk Based Monitoring
- Quality Assurance visits
- Patient Recruitment
- Patient Retention and Site Engagement
- Medical Monitoring and Patient Eligibility
Data Management
Our globally compliant team of clinical data managers and programmers ensures the integrity of your data. We offer electronic data capture, data validation, and cleaning, utilizing industry-standard tools and practices, ensuring you robust data at every milestone.
- Database Lock and Archiving
- Electronic Data Capture
- Data Validation and Cleaning
- Database Design
- Data Visualization
- SAE Reconciliation
- MedDRA & WHODD Medical Dictionaries
- Data Quality Review & Controls
- Medical Review of Data
- External Data Handling and Reconciliation
- Medidata RAVE, INFORM, Veeva Vault EDC, Empirical EDC, Oracle RDC Certified Professionals
- 24*7 EDC Helpdesk
Biostatistics and SAS Programming
Our seasoned biostatisticians and statistical programmers apply their scientific and medical knowledge to your clinical development process. From sample size calculations to statistical report generation, we provide comprehensive biostatistical services to guide your research.
- Sample Size Calculation
- Statistical Inputs in Protocol
- Statistics Analysis Plan and Mock Shells
- Statistical Programming
- TLF and Validation Programming
- CDISC Compliant Data (SDTM & ADaM)
- Statistical Report
- Meta- Analysis
- SAE Narratives
- ISS/ISE
- DSMB/DMC support
- E-Submission package
Medical and Regulatory Writing
Our expert medical writers are skilled at navigating the intricacies of a highly regulated environment. From protocol to clinical study reports and other regulatory documents, we deliver precision and compliance, meeting the requirements of regulatory agencies across all phases of clinical trials.
Our core medical/ regulatory writing services:
- Informed Consent Document
- Investigator Brochures
- Protocol
- Clinical Study Report
- SAE Narratives
- Toxicological Database
- Safety Documents: PSUR/ DSUR, SDS/MSDS, PBRER, PADERS, Signal Detection, RMPs
- CTD Dossiers
- CEP, CER, CAPA Report, Labels
- IFU/ DFU
- Device Master File, Plant Master File
- Standard Response Documents, Post-Marketing Surveillance Data Reports
Scientific Communication
We tailor our solutions to bridge key communication gaps. And we've perfected our processes across a range of mediums, ensuring your message reaches the right audience effectively through:
- Education or Engagement Modules
- Slide Decks
- White Papers
- Infographics
- Conference Abstracts and Posters
- Original Study Manuscripts
- Review Articles: Narrative and Systematic
- Targeted Literature Review Report
- Advisory Boards
- Consensus Manuscripts
- Journal Submission
- Literature Search