Jeevan science technology

Clinical Trial Services

We at Jeevan Scientific offers a broad range of Clinical Trial Services from Phase II to IV for Pharmaceutical, Biotechnology and Medical Device to bring new drugs and devices to global reach faster. We also extend our services to other areas like Cosmetics and Neutraceuticals.

We always believed in one standpoint- Global Reach with Local Expertise. With a strong experience in conducting clinical trials, JSTL has the global reach and capability to conduct clinical studies and navigate through regulatory requirements for Investigational New Drugs, Abbreviated New Drug Applications, WHO and various Local regulatory agencies.

Backed by strong clinical and therapeutic expertise, we take a highly flexible and customized approach to clinical research by listening closely to our customers and tailoring our services to their unique needs and projects.

Medical Writing

The 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 serve 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 the highest standards of focus on 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 well-being 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 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 Management

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:

  • Bio-statistical 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

Quality Assurance Management

We have an independent quality assurance department that engages 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, 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