Late Phase Services

Clinical Trial Feasibility

The Right Start for Reliable Results!

At Cliantha, we bring in-depth expertise in clinical trial feasibility, ensuring that every study is set up for success from the start. Our approach combines thorough site assessments, real-world data analysis, and strategic planning to evaluate study requirements and identify potential challenges. By conducting comprehensive feasibility studies, we help clients make informed decisions, optimize site selection, and ensure timely recruitment, all while adhering to regulatory standards.

With a deep understanding of diverse therapeutic areas and global regulations, we tailor our feasibility assessments to align with your specific study needs, reducing risks and enhancing the likelihood of smooth trial execution.

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Medical Services

Medical Writing

  • Protocol
  • Clinical study report
  • Informed consent document
  • Assent form
  • Subject diary
  • Patient support aids (Thank you letter, Participant ID card, Study advertisement material, etc.)

Regulatory Writing

  • Investigator’s Brochure (IB)
  • Clinical Development Plan
  • Clinical & non-clinical sections of the Common Technical Document (CTD) including summaries and overviews for EMA and other Regulatory Authorities
  • IND, 505(b)(2) and pre-EMA meeting briefing packages
  • Executive Summary for DCGI submission
  • Web synopses (Clintrial.gov, EU clinical register, CTRI, etc.)

Accelerating late-phase clinical trials through regulatory excellence

Driving efficiency and compliance through centralized eTMF management

Navigating regulatory pathways is critical to the successful execution of late-phase clinical trials. Our Regulatory Affairs team provides comprehensive support for clinical trial registrations, ensuring timely submissions and compliance with global regulatory requirements.

With extensive experience in managing regulatory documentation and submissions for Phase II–IV studies, we work closely with sponsors, investigators, and regulatory authorities to streamline approval processes. From protocol submissions and ethics committee coordination to regulatory amendments and ongoing compliance management, our team ensures efficient study start-up and uninterrupted trial conduct.

Our deep understanding of regional and international regulatory frameworks enables us to accelerate late-phase clinical trial approvals while maintaining the highest standards of quality and compliance.

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Clinical Project Management

At Cliantha, our project management services are led by professionals with extensive industry and therapeutic area expertise across all phases of clinical development. Additionally, our strong relationships with trial sites, key opinion leaders, and Principal Investigators enable rapid trial start-up, efficient patient recruitment, and optimized site selection—ensuring timely and successful trial execution

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    Our Clinical Project Managers oversee every aspect of clinical trials, providing:

    Regulatory Submissions

  • Our team handles submissions to regulatory authorities and ethics committees, ensuring timely trial initiation.

    • Sample Size Determination

  • We determine the optimal sample size to achieve statistically significant results.

    • Data Management

  • We ensure data accuracy and integrity through comprehensive data management oversight.

    • Resource Allocation

  • We strategically assign key personnel, including Clinical Research Associates (CRAs), and implement robust monitoring plans to enhance trial efficiency

Clinical Operations

Driving Excellence at Every Step of the Trial

At Cliantha, we specialize in providing end-to-end clinical operations services, ensuring that each phase of your clinical trial is handled with precision and expertise. Our team of experienced professionals works closely with clients to design and execute tailored clinical studies that meet global regulatory standards.

From patient recruitment and site management to data collection and analysis, we focus on delivering reliable, high-quality results. Our strong network of clinical sites and a commitment to excellence make us a trusted partner in driving the success of clinical trials across various therapeutic areas.

With a focus on compliance, patient safety, and efficiency, Cliantha ensures seamless project execution, helping clients bring their products to market with confidence.

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Our Services

  • Worldwide feasibility studies
  • Study start-up including site identification, qualification, and selection
  • Study document development
  • Essential document collection and maintenance
  • Translations
  • Trial Master File set-up and maintenance
  • Site monitoring and management
  • Patient recruitment and retention strategies
  • Clinical trial management system
  • Training of clinical associates
  • CRA management and quality control
  • Audit preparation
  • IRB/EC submissions
  • Third-party vendor management

Risk-based Clinical Monitoring

Real-Time Oversight, Ensuring Data Integrity and Trial Efficiency

Central Monitoring is a vital aspect of modern clinical trials, designed to oversee and manage data remotely from a central location. This approach enhances the efficiency, accuracy, and quality of clinical trials by offering real-time monitoring and analysis of data from multiple study sites. At Cliantha, we leverage cutting-edge technologies and data analytics to ensure that every aspect of your clinical trial meets regulatory standards and performs optimally.

Cliantha's Tailored Monitoring Approach: Adapting to Your Clinical Trial’s Unique Needs

Cliantha utilizes a tailored, adaptive monitoring approach that prioritizes subject safety and data integrity by identifying protocol elements with the highest impact. Our comprehensive strategy includes:

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Protocol Evaluation

We assess critical study elements, identify potential risks, and develop mitigation strategies to ensure study integrity and safety.

Centralized Monitoring

Early identification of quality, safety, and operational risks is achieved through centralized data reviews and remote monitoring, enabling proactive intervention.

On-site Visits

For tasks requiring source verification that cannot be handled remotely, we conduct on-site visits to provide in-person support, address identified issues and offer training or re-education where necessary.

With this adaptive approach, Cliantha ensures optimized monitoring, enhanced trial performance, and minimized risks throughout the study lifecycle.

Experience Precision and Efficiency with The Cliantha Advantage in Clinical Monitoring

At Cliantha, we implement a robust Risk-Based Monitoring (RBM) framework tailored to each study, ensuring an efficient monitoring strategy while safeguarding patient welfare and data integrity. This dynamic approach consists of four key stages, continuously refined for optimal performance:

    Protocol Evaluation

  • A comprehensive protocol review determines the ideal balance of remote, on-site, and centralized monitoring to enhance study oversight.

    • Establishing Controls

  • Cliantha’s SOPs provide built-in controls, further customized through Project Governing Documentation, Project Plans, and tailored training.

    • Centralized Monitoring

  • Continuous data oversight, including medical surveillance and operational analytics, enables early risk detection and proactive management.

    • Risk Remediation

  • Identified risks trigger immediate actions such as additional monitoring, targeted site training, and study plan adjustments to maintain compliance and study success.

This adaptive framework ensures streamlined monitoring, regulatory adherence, and high-quality outcomes for every clinical trial.

Technology: Real-Time Insights for Actionable Outcomes

Code EDx is an advanced, interactive analytics platform designed to consolidate multiple sources of unstructured data into user-friendly dashboards. By integrating diverse data streams—including central lab, EDC, IRT, Electronic Health Records, eConsent, eDiaries, and direct-to-patient services such as home health, study product logistics, and travel support—our platform enables comprehensive data aggregation and analysis.

With intuitive visualization tools, Code EDx helps identify trends, outliers, and key insights across operational, clinical, and safety data. This real-time access allows study teams to make informed, forward-looking decisions with ease. The self-service dashboards further enhance flexibility, enabling teams to customize and share findings effortlessly.

    Tailored Dashboards:

  • Custom-built study-specific dashboards aligned with unique project risks.

    • Multi-Level Reporting

  • Data visualization and analysis at patient, site, country, study, and program levels to track trends and outliers.

    • Risk Mitigation & Oversight

  • Enables rapid anomaly detection, proactive risk management, and issue escalation for continuous study optimization.

    • Enhanced CRA Monitoring

  • Supports remote monitoring by providing CRAs with centralized data review capabilities, reducing on-site visits while ensuring high-quality site engagement and education.

Code EDx empowers study teams with real-time, data-driven decision-making, optimizing trial oversight while maintaining efficiency and compliance.

1 Proactive Risk Management through Integrated Multidisciplinary Collaboration

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Risks can emerge at any stage of a clinical trial, and Cliantha’s cross-functional expertise ensures proactive identification, mitigation, and continuous monitoring throughout the study lifecycle. A key differentiator is the deep involvement of our physicians, who play an integral role in trial execution.

Risk-Based Monitoring (RBM) is strengthened by comprehensive medical oversight, with Medical Monitors leading surveillance and ongoing reviews, supported by safety coordinators, and a dedicated team of data clinicians who track each patient’s journey.

The study leadership team—comprising the Medical Monitor and Clinical Trial Manager—maintains a dual focus on both clinical and operational data, ensuring risk is managed effectively while optimizing study integrity and patient safety.

2 Cliantha's Tailored Monitoring Approach: Adapting to Your Clinical Trial’s Unique Needs

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Cliantha utilizes a tailored, adaptive monitoring approach that prioritizes subject safety and data integrity by identifying protocol elements with the highest impact. Our comprehensive strategy includes:

3Sites & Patient Focus

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With over 2 decades of experience, Cliantha has built and sustained strong partnerships with thousands of investigators and research sites globally. We recognize that minimizing site burden is essential for fostering collaboration and ensuring efficient study execution. As we implement study-level monitoring adjustments, we work closely with sites to develop strategies that seamlessly align with their workflows

4CRA Training & Development – The Foundation of Excellence

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With over 2 decades of experience, Cliantha has built and sustained strong partnerships with thousands of investigators and research sites globally. We recognize that minimizing site burden is essential for fostering collaboration and ensuring efficient study execution. As we implement study-level monitoring adjustments, we work closely with sites to develop strategies that seamlessly align with their workflows

Electronic Trial Master File (eTMF)

Driving efficiency and compliance through centralized eTMF management

At Cliantha Research, we offer centralized Electronic Trial Master File (eTMF) services designed to ensure efficient, compliant, and inspection-ready clinical trial documentation. Our dedicated eTMF team manages the complete lifecycle of trial documents—from setup and migration to ongoing maintenance and quality control.

Leveraging standardized processes and advanced eTMF platforms, we ensure accurate document filing, real-time tracking, and regulatory compliance with global standards such as U.S. Food and Drug Administration and European Medicines Agency guidelines. Our centralized approach improves document oversight, enhances collaboration across study teams, and ensures your Trial Master File always remains audit-ready.

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Clinical Trial Supply Management

Clinical Trial Supply Management Ensuring Timely Delivery, Accurate Distribution, and Seamless Execution

Clinical trials come with a range of logistical challenges. Whether you're overseeing a small regional study or a complex global trial, a robust supply chain network with local expertise and strong connections to authorities is crucial.

At Cliantha, we collaborate with you to develop a supply chain management strategy that aligns with the specific needs of your protocols and patients.

Our Clinical Trial Supply Management services offer a comprehensive end-to-end solution for investigational products (IP), comparator drugs, and ancillaries. By leveraging our extensive in-house clinical supply chain expertise and a reliable partner network, we provide cost-effective solutions while ensuring the timely completion of studies.

Our Capabilities

Dedicated Software & SOPs

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Comprehensive systems for procurement, storage, distribution, return, destruction, and retention sample management for temperature-controlled products.

Temperature-Controlled Storage

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Comprehensive systems for procurement, storage, distribution, return, destruction, and retention sample management for temperature-controlled products.

  • +2°C to +8°C
  • +15°C to +30°C
  • Below -20°C

Proven Expertise

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  • Over 2,000 controlled temperature shipments experience over the year for 40+ clinical trial studies.
  • 4,000 sq. ft. exclusive temperature-controlled storage facility dedicated to investigational products and supplies.

24×7 Engineering Support

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Continuous temperature monitoring via Eurotherm system with power backup for uninterrupted control along with engineer staff available for 24 x 7.

Instrument Management

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Dedicated staff for procurement, calibration, and distribution. 3,000+ instruments calibrated and deployed to clinical sites within a year.

Seamless Logistic Support

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Annually more than 6100 non-controlled temperature shipments of various materials regarding clinical trials within a year.

More than 7500 no. of central lab shipment done within a year.

Customs Clearance

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Average 450 international shipments are made within year without Hassle.

Sample Collection Support

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Fo Average 18000 Kits prepared for sample collections at sites and distributed to sites with support of phlebotomist support within a year.

Vendor Collaboration

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  • Qualified vendors for primary & secondary packaging
  • Qualified vendor for IWRS

Quality Assurance Oversight

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Ensuring compliance with global standards throughout the supply lifecycle.

Operational Support

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We simplify clinical trial operations with comprehensive support services:

  • Financial Management: Secure and transparent payment processes for Principal Investigators and Ethics Committees using advanced software. More than 3000 PI grant invoices proceed within a year.
  • Travel Desk: Around 3500 travel requests and expenses proceed within a year with the support of 24×7 availability with advanced booking systems and dedicated staff.

Scientific Writing and Medical Communication

Medical Oversight

  • Medical Overview of the clinical trials – Eligibility and Data review
  • Training of Study Teams and sites
  • Prepare presentations and attend meetings at DCGI and other regulatory agencies
  • On-site monitoring
  • Perform data analysis to identify patterns and trends
  • Feasibility studies & reports, disease demographics from India and other regions

Publication Support

  • Original research articles
  • Review articles
  • Case reports
  • Systematic reviews
  • Conference abstracts
  • Scientific posters for conference
  • Oral presentation slides
  • Lay summaries for public disclosure

Medical Affairs and Educational Materials

  • Medical Information (Slide decks for medical science liaisons)
  • Medical inquiry responses (Frequently asked questions (FAQs)
  • Digital content for medical marketing (e.g., websites, apps)
  • Product monographs
  • Patient education materials
  • Scientific training modules
  • SOPs and process guides
  • Compliance training materials

eClinical Systems

21 CFR Part 11 regulatory Compliant EDC
Clinical Trial Management System
Clinical Trial Management System
Interactive Web Response System
Interactive Web Response System
21 CFR Part 11 Compliant Web enabled Trial Master File
21 CFR Part 11 Compliant Web enabled Trial Master File
21 CFR Part 11 Regulatory Compliant Web enabled Secure clound based remote monitoring software
21 CFR Part 11 Regulatory Compliant Web enabled Secure clound based remote monitoring software
21 CFR Part 11 Regulatory Compliant eLearning System
21 CFR Part 11 Regulatory Compliant eLearning System
Web-based Customer Relationship Management
Web-based Customer Relationship Management
Subject Eligibility Review
Subject Eligibility Review
Electronic Data Review Tool
Electronic Data Review Tool

Rescue Study

Reviving Trials, Delivering Results

Clinical trials are inherently complex, and even the most meticulously planned projects can encounter unforeseen issues that derail progress. In these situations, a well-chosen rescue intervention can quickly realign the project and bring it back on schedule.

With a deep understanding of diverse therapeutic areas and global regulations, we tailor our feasibility assessments to align with your specific study needs, reducing risks and enhancing the likelihood of smooth trial execution.

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What is Rescue Study?

A rescue study in clinical research serves as a rapid intervention when a trial encounters critical issues or early signs that it may fail to demonstrate the necessary drug efficacy. These issues can include Resource shortages and operational challenges, compromised data quality, lapses in regulatory compliance or. missed deadlines. At times, a clinical trial may suddenly find itself in need of additional services not initially planned for. This unexpected requirement can disrupt the project timeline and lead to substantial delays. The primary goal is to quickly address the challenges to enable the trial to move forward effectively. This process often involves revising the trial’s design, improving participant recruitment and management, ensuring accurate data collection, and tackling any operational or resource challenges. Ultimately, a rescue study is designed to protect the investment in the trial and ensure the reliability of its outcomes.

At Cliantha, our seasoned experts address challenges and implement tailored strategies to rescue your trial and get it back on track, the derailed project. With 2 decades of experience in the clinical research industry, Cliantha has established itself as a preferred CRO for rescue studies. Our expertise spans efficient, data-driven transition processes through our expert biometrics and regulatory teams, seamless technology transitions, and comprehensive regulatory gap analyses-all designed to get your trial back on track.

Looking for a Rescue CRO? Cliantha’s expertise can help. Get in touch with an expert today.

Retrospective Research

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    The Right Start for Reliable Results!

    Retrospective Research evaluates the effects of interventions in real world scenarios to demonstrate value through comprehensive database analysis.

    Retrospective research plays a crucial role across Phases I–III and post-launch, providing valuable insights into:

  • Intervention Effectiveness: Assessing real-world treatment outcomes.
  • Safety Profiles: Monitoring long-term safety and adverse events.
  • Patient Outcomes: Evaluating treatment impact on quality of life.
  • Cost-Effectiveness: Analyzing the economic value of interventions.
  • Utilization Patterns: Understanding treatment adoption and adherence in clinical

Cliantha Research: Rescuing Trials, Redefining Success

Bringing together a unique and proven blend of deep therapeutic area domain expertise, scientific rigor, operational excellence, and access to unparalleled data assets, Cliantha can deliver real evidence with real confidence.

Want to measure the effects of treatments in real world scenarios using retrospective database research? Learn how Cliantha’s expertise can help. Get in touch with an expert today.

Research delivered with Integrity

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