Project Management
Efficient Project Planning & seamless execution Allocation of Project Resources Ste Feasibility, Site Identification and Assessment Vendor Management Clinical Trial Supply Management Develop Monitoring plan CRA Training Monitoring visit Report Review and Submission Proactive Risk Management Quality Assurance
Clinical Trial Monitoring
Site initiations Regulatory and protocol compliance monitoring Obtaining local EC/IRB approvals Supply inventory management Training to project and site teams DSMB support
Site Management
Site management team bridges the gap between sites and sponsor/CRO in accelerating patient enrollment and effectively managing the trial from start to finish; thus ensuring smooth transit of the trials to the next phase. Protection of research subjects Ensuring accurate of data Regulatory submissions of site documents Site preparation for the clinical trial Interacting with Ethics Committee CRO coordination Labs coordination Maintaining clinical trial documents/records IP accountability
Regulatory support
IND/Phase I Clinical Trials dossier submissions Phase II, III and IV clinical trials approvals for drugs Pilot and pivotal studies approvals Import licenses for investigational products Export licenses for biological/samples Marketing authorizations for drugs Scheduling patients’ visits and ensuring retention till study completion, Keeping the investigator informed and compliant
Medical & Scientific Writing
Provide solutions for your regulatory submissions and publications to add value. Protocols Investigators Brochure Clinical Study Report Patient Documents like Informed Consent Forms Review Articl Manuscripts Case Studies Conference Abstracts
Phase IV Studies
Various services include Post-authorization safety studies Product/ Disease registries Prospective observational cohort studies New indication/formulation trials Special populations (e.g., pediatric, elderly) Patient surveys Adherence and compliance programs Patient-reported outcomes (PRO) Quality of life studies Prospective and retrospective studies Practice-based research networks
Clinical Data Management
CRF designing Database designing and study setup Data entry Clinical coding with industry standards and client-specific dictionaries Reconciliation of external data Data validation and query resolution Project management of data and technical services
Biostatistics
Statistical inputs for protocol design Sample size calculation statistical analysis plan preparation Randomization planning SAS programming for interim and final analysis providing support for regulatory and advisory meetings
Good Clinical Practice Training
GCP Training Service includes meeting the regulatory guidelines and generation of quality data. Training will be provided to the following people. Certificates will be provided after training evaluation.