Clinical Trial
Clinical Operations
ClinEnthous dedicated team can help manage your most important clinical trials. From start to finish, we’ll ensure that all aspects of your trial are professionally handled with quality and integrity of data always at the forefront while establishing the shortest route to market for your product.
Take a look at our integrated clinical research services:
✈ Early Phase Clinical Studies
✈ Late Phase Clinical Studies
✈ Epidemiological Studies
✈ Real World Evidence Studies
✈ PMS Studies
✈ Short surverys
Clinical Trial Monitoring
ClinEnthous team will ensure complete control of the monitoring services at sites. Our monitors are highly skilled, therapeutically aligned, trained and committed to excellence in every study with the highest standards of focus towards protecting patient safety, well being, rights and data integrity.
Our monitoring services include:
✈Site Feasibility, Qualification & Selection Support
✈Initiation, Routine Monitoring & Closeout Visits
✈Source Documentation Review & Data Verification
✈Risk-Based Monitoring services
✈Participation & Presentation at Investigator sites
✈Study Supply Inventory
✈Reporting of Adverse Events & Serious Adverse Events
Quality Assurance
We have quality assurance auditors who engage in ongoing quality and compliance assessments of all the services we offer for your clinical studies. In particular, we regularly conduct internal process audits to ensure compliance with applicable good clinical practices, standard operating procedures and vendor qualifications.
Our Quality Assurance and Compliance Services are focused on different areas of audits:
✈ Project audits: investigator files/site audits, trial
master file audits,database audits, statistical
report audits, clinical study report audits and
regulatory submission audits.
✈ Process audits & Vendor audits
✈ Pre-inspection Support
eTMF services
Electronic Trial Master File (eTMF), e-Archiving and Data Storage Solutions
ClinEnthous provides electronic trial master file (eTMF) solutions and other support services to the global clinical research market.
We offer an unique combination of technology, quality and services that deliver a range of flexible, targeted solutions to the clinical research industry. The company promotes TMF excellence by focusing on efficient management of clinical trial documents, paper and electronic documents.
ClinEnthous will create and maintain an inspection-ready eTMF that you can count on. By working with large and small organisations on a global level, the team here at ClinEnthous has gained a detailed understanding of accurate and complete TMF, enabling the evaluation of a clinical trial.
Project Management
Project Management is our major competence. Our team works effectively and meticulously to manage all critical aspects of the trial to ensure on-time delivery of results, within reasonable budgets and with the highest quality output.
Our Clinical Trial Management services include:
✈ Clinical Study Contracts, Budgets and Project Timelines
✈Work Directly with IRBs and competent authorities on behalf of Sponsor
✈ On-site Monitoring Management
✈ Training for CRAs and site personnel on the study related procedures
✈Inspection & Audit Readiness
✈CAPA, Risk Assessment and Mitigation Plans
Medical Monitoring
Our Medical Monitoring services include:
✈ Preparation and review of clinical development plan of various molecules
✈ Assist and review clincal study design for different phases of study
✈ Preparation of Medical Monitoring (MM) and
Safety Management (SM) plans of clinical studies
✈ Review/analyze safety/efficacy trends for data generated
✈ Prepare/advice regulatory subject expert committee (SEC) presentations and other documents
✈ Review clinical study documents – IB, ICF, PIS, CSR etc.
✈ Assist in safety reporting of adverse events
✈ Providing protocol and therapeutic area trainings to all stakeholders
✈ Support in MedDRA/ATC coding.
Medical Writing
We offer a wide range of Medical Writing services to help you compile, organize, write, edit and produce a wide range of medical and scientific documentation required to support your clinical development programs.
Our Medical Writing Services include:
✈Protocol Development
✈Inform Consent Forms (ICF), Case Report Forms (CRF) and Patient Information Sheet (PIS)
✈Clinical Study Reports (CSR)
✈Briefing Books, Direct Healthcare Professional Communications (DHPC)
✈Clinical Summary and Clinical overview documents for eCTD submissions
✈Patient Safety Narratives
✈Literature search submissions.
Regulatory Affairs
ClinEnthous Regulatory team provides comprehensive support for our Sponsors/Clients to overcome the hurdles linked with the requirements of the DCGI, FDA, EMA and Other Regulatory Bodies.
We have a remarkable track record of getting on time approvals for clinical trials, from different regulatory jurisdiction. We help our Sponsors/Clients understand the requirement of respective Regulatory Authority and assist them appropriately to avoid any delay in approval.
Preparing regulatory package for Regulatory Authorities. Coordinating and submitting Protocol or Protocol Amendments.
Communication and follow up with competent authorities including DCGI, FDA and EMA. Study and Investigator submissions to Ethics Committees and IRBs. Study Registration on respective registries, and other trial databases.
Statistical Services
ClinEnthous has partnered with some of the market leaders to provide statistical services for clinical trial.
✈ Preparation/review of Statistical Analysis Plans (SAP)
✈ Preparation/review of Tables, Listings and Figures
(TLF’s)
✈ Statistical data analysis for understanding
significance