Clinical Research Services

Nilasari Comprehensive Site Management and Clinical Research Services

At Nilasari, we offer a full suite of clinical research services to ensure the successful execution and management of your research projects. Our Site Management Organization (SMO) services cover every aspect of clinical trial management, from feasibility analysis to investigator training, data management, and compliance monitoring. We specialize in delivering seamless, high-quality support to help you navigate the complexities of clinical trials, ensuring regulatory compliance and data integrity throughout the process.

End-to-End Research Project Setup and Management

Our Site Management services encompass all stages of a clinical research project, providing a one-stop solution for sponsors and research teams. Whether you are launching a new study or optimizing an ongoing trial, Nilasari offers expert guidance and management services to help you streamline operations and achieve your research objectives.

Site Feasibility Procedures

We conduct thorough site feasibility assessments to determine the suitability of research locations, ensuring that the selected sites meet all criteria for trial success.

Ethics Committee (EC) Establishments, Submissions and Approvals:

Our team handles the establishment and updates of ethics committees, project submissions and follow up, ensuring that all required documentation is completed accurately for timely approval.

Investigator Selection and Training:

Nilasari assists in selecting qualified investigators and provides training on study protocols, GCP (Good Clinical Practice) standards, and regulatory requirements to ensure high-quality and compliant clinical trials.

Research Team Selection and Training:

We help you assemble the right team, providing tailored training programs to ensure that all research personnel are equipped with the necessary skills and knowledge for effective trial execution.

Comprehensive Site Monitoring & Data Management

Site Management and Monitoring:

Nilasari ensures that research sites operate efficiently by overseeing daily operations, managing site performance, and performing regular monitoring visits to verify data accuracy and compliance with study protocols.

Source Data Verification (SDV):

We perform detailed source data verification to ensure that clinical trial data is accurate, reliable, and consistent with the source documents, minimizing errors and improving trial outcomes.

Investigational Product (IP) Management:

Our team manages the storage, distribution, and accountability of investigational products (drugs or devices) to ensure compliance with trial protocols and regulatory guidelines.

Data Entry and Data Management:

We offer robust data entry and management services, ensuring accurate and timely collection, analysis, and reporting of trial data to support decision-making.

Auditing for Quality Assurance and Compliance

At Nilasari, we conduct rigorous audits to assess the adherence to study protocols, regulatory requirements, and industry quality standards. Our auditing services are designed to:
  • Identify gaps or areas of non-compliance
  • Offer actionable recommendations for continuous improvement
  • Mitigate risks related to regulatory violations, data discrepancies, or protocol deviations
By proactively addressing potential issues, we ensure that your clinical trials stay on track and in full compliance with all relevant regulations.

ICH GCP Certification Programs (with CME Credits)

Nilasari offers International Council for Harmonisation (ICH) GCP Certification Programs to keep clinical research professionals up-to-date with global standards. These certification programs:
  • Equip professionals with the knowledge to conduct ethical, compliant, and scientifically sound clinical trials.
  • Include options for Continuing Medical Education (CME) credits, allowing professionals to maintain certification while enhancing their career growth.
  • Help ensure that research teams adhere to the latest ICH GCP guidelines and industry best practices.

Services for Students and Academic Scholars in Clinical Research

Nilasari provides job-oriented clinical research courses tailored for students and academic scholars. These programs are designed to bridge the gap between academic knowledge and industry demands, offering career-focused training and practical support in the clinical research field.
  • Hybrid/Weekend Clinical Research Courses:
    Our flexible, job-oriented programs are available in hybrid or weekend formats, making them ideal for working professionals or students looking to enter the clinical research field.
  • Research Support for Graduate and Postgraduate Students:
    Nilasari offers comprehensive research support, including proposal writing, site selection, regulatory submissions, and publication assistance.
  • Career Opportunities in Clinical Research:
    We guide students through the various career opportunities in clinical research, including fields like nursing, pharmacy, MBBS, BDS, BHMS, and Ayurveda. We also offer placement support, including CV writing and mock interview assistance.
  • Internship Opportunities:
    Nilasari provides valuable internship opportunities for newcomers to the clinical research industry, either within Nilasari or with our partner organizations. These internships provide hands-on experience to kickstart careers in clinical research.

Why Choose Nilasari for Site Management and Clinical Research Services?

  • Comprehensive, End-to-End Solutions:
    From feasibility assessments to investigator training and data management, Nilasari offers a full spectrum of services for clinical trials.
  • Expert Guidance and Support:
    Our team of seasoned experts ensures that your research project adheres to industry standards and regulatory requirements, keeping your trials on track and minimizing risks.
  • Quality and Compliance Assurance:
    With rigorous auditing and GCP certification programs, Nilasari ensures that your trials maintain the highest standards of quality and compliance.
  • Training for Career Advancement:
    Nilasari not only offers clinical research services but also supports future professionals with specialized training programs, internships, and job placement assistance.

GCP Training and Auditing Services

Nilasari offers specialized Good Clinical Practice (GCP) Training and Auditing Services to support clinical research organizations, hospitals, investigators, and site management teams in meeting international ethical and regulatory standards.
As an independent consulting and oversight partner, we help ensure that clinical trials are conducted with the highest level of patient safety, data integrity, and regulatory compliance. Whether you are setting up a new trial site, training investigators, or preparing for inspections, Nilasari provides end-to-end expertise.

Why GCP Matters

    Good Clinical Practice (GCP) is a globally recognized standard established by ICH (International Council for Harmonisation) and adopted by regulatory authorities such as CDSCO, DCGI, US FDA, and EMA. Compliance ensures:

  • Protection of trial participants’ rights, safety, and well-being
  • Credible and reliable clinical data
  • Adherence to ethical and regulatory guidelines
  • Readiness for audits and inspections by regulatory bodies

Our Services

  • 1. GCP Training:
    We provide customized training programs for all stakeholders involved in clinical research:
  • For Investigators & Site Teams
    Practical training on protocol adherence, informed consent, subject safety, and documentation.
  • For Sponsors & CROs
    Comprehensive programs on monitoring, reporting, and quality oversight.
  • For Ethics Committees
    Training on responsibilities, review procedures, and compliance with GCP and local regulations.
  • Our training modules are interactive, scenario-based, and designed to build real-world application skills.

2. GCP Auditing

    Our auditing services ensure that your clinical trials meet international quality benchmarks:
  • Site Audits
    Assessing investigator sites for compliance with GCP, SOPs, and regulatory requirements.
  • System Audits
    Reviewing SOPs, data management, and trial documentation processes.
  • Vendor Audits
    Evaluating CROs, laboratories, and service providers for compliance.
  • Mock Inspections
    Preparing organizations for regulatory inspections by simulating real audit scenarios.

Who We Support

  • Clinical Research Organizations (CROs)
  • Site Management Organizations (SMOs)
  • Hospitals and Academic Institutions conducting research
  • Independent Ethics Committees (IECs)
  • Pharmaceutical and Biotechnology companies

Frequently Asked Questions (FAQ)

  • 1. What is included in your Site Management Services?
    Our Site Management services include site feasibility assessments, investigator selection, EC submissions, training for research teams, and site monitoring. We ensure that all sites meet regulatory and protocol requirements, and we monitor trial progress to ensure quality and compliance.
  • 2. What is the importance of auditing in clinical research?
    Auditing helps identify potential risks or areas of non-compliance before they affect the study. It ensures that all trial processes meet the highest standards, reduces the likelihood of regulatory violations, and improves overall trial performance.
  • 3. How does Nilasari assist with investigator and research team training?
    We provide specialized training programs tailored to each role within the clinical trial. This includes investigator training on protocols and GCP guidelines, as well as training for clinical research associates, data managers, and other personnel involved in the trial.
  • 4. Do you offer GCP certification programs?
    Yes, Nilasari offers ICH GCP certification programs, including options for CME credits. These programs are designed to help clinical research professionals maintain certification and stay up-to-date with the latest regulatory standards.
  • 5. What types of clinical research training do you offer for students?
    We offer job-oriented clinical research courses in hybrid and weekend formats for students and professionals. We also provide research support for academic scholars and offer placement assistance, including CV writing and mock interview coaching.
  • 6. Do you provide internship opportunities in clinical research?
    Yes, Nilasari offers internship opportunities for students and newcomers to the clinical research field, providing hands-on experience and the chance to develop practical skills in the industry.
  • 7. How can Nilasari help with regulatory submissions?
    Nilasari assists with Ethics Committee (EC) submissions and approvals, ensuring that all necessary documentation is in place and submitted in compliance with local and international regulations.
  • 8. What are the benefits of working with Nilasari?
    Working with Nilasari gives you access to end-to-end clinical research services, expert guidance on compliance and quality standards, and training programs that equip your team with the skills needed to succeed in clinical trials. Additionally, we offer support for career development, including internship and job placement services.

Get in Touch with Nilasari

For more information about our Site Management and Clinical Research Services, or to schedule a consultation, contact Nilasari today. We are here to support your clinical research needs with comprehensive, tailored solutions that ensure success and compliance at every stage.

Contact Nilasari today