Medical Writing Services group at JSTL is uniquely qualified to help you compile, organize, write, edit, and produce a wide range of medical and scientific documentation required to support your clinical development programs. JSTL Medical writing panel includes Physicians, they work closely with key operational departments to access a fully integrated network of information.
- Protocol Development
- ICDs, CRF and IBs design
- Clinical Study Reports
- Clinical Summary and Clinical overview documents for eCTD submissions
- Patient Safety Narratives
- Literature search submissions
Clinical Trial Management
Our Project Managers (PMs) and APMs have operational and regulatory expertise in handling global and local multicentre clinical trials. Our PMs serves as a primary resource and point of communication for the client and project team. Our PM team works effectively and meticulously to manage all critical aspects of the trial to ensure on-time delivery of results, within budget and with the highest quality output.
Our Clinical Trial Management Services include
- Clinical Study Contracts & Budgets, management of SOW and Project Timelines
- Work Directly with IRBs and competent authorities on behalf of Sponsor
- Trial, Site, Patient Management, and CTMS
- In-house and On-site Monitoring Management
- Training for CRAs and site personnel on the study related procedures and applicable regulations
- Inspection & Audit Readiness, CAPA, Risk Assessment and Mitigation Plans
Clinical Trial Monitoring
Jeevan Scientific has a pool of Clinical Research Associates (CRAs), who ensure the integrity of the study. Our CRAs are highly skilled, therapeutically aligned, trained, and committed to excellence in every study with 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 Meetings
- Identification & Addressing of Protocol Deviations & Violations
- Study Supply Inventory
- Reporting of Adverse Events & Serious Adverse Events
Drug Safety Management
Subject safety and wellbeing is the primary aspect of a clinical study. Our experienced group of physicians will serve as a link between our sponsors and the investigative sites.
We offer safety monitoring and medical management support for your clinical studies. Our team of physicians will leverage their clinical experience and practical knowledge in the conduct of a clinical study.
Our medical monitors shall provide:
- Protocol and study-specific training to the investigators
- Response to subject evaluation criteria questions
- Safety monitoring– AE and SAE management
- Support in regulatory agency representation
Clinical Data Management
Clinical Data Management (CDM) is a critical phase in clinical research and the integrity of clinical data is of paramount importance to a successful project. We ensure the integrity by strict adherence to established standard operating and review procedures at every stage of the project. Our data is delivered with quality assurance at every step and data management systems are in compliance with FDA 21 CFR Part 11 and industry guidelines for managing data.
Our Data Management Services:
- Clinical Data Management Plan
- pCRF/eCRF Testing
- Edit Check Testing
- Data Entry/Quality Control
- Discrepancy Management
- Medical Coding and SAE Data Reconciliation
- Data Base Lock Support and Archival
Biostatistics & Statistical Programming
Our team of biostatisticians and statistical programmers apply their deep knowledge of the regulatory environments to help you navigate through complex areas of study design, sample size, number of studies, analysis methods, data displays and interpretation of results from Clinical studies as well as the definition of study objectives or endpoints.
Our Services are:
- Biostatistical consulting- Trial Design Inputs
- Sample size calculations and Generate randomization schedules
- SAP – Creation
- ADaM Dataset – Specifications, Creation, Validation
- TLFs – Creation, Validation
- PK/PD Analysis
- Statistical Analysis Report
We have an independent quality assurance department that engages 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, vendor qualifications, and commitments to clients – all of these are for the purpose of consistently ensuring the quality of our services remains at the highest level.
Our Quality Assurance and Compliance Services are focused on three main 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