Comprehensive Clinical Trial Support Services
Accelerating Clinical Research with Expert Trial Management & Regulatory Compliance
Clinical trials are the cornerstone of evidence-based medicine, ensuring the safety, efficacy, and regulatory approval of new drugs, biologics, and medical devices. However, managing a clinical trial requires meticulous planning, regulatory expertise, data management, and biostatistical analysis to ensure compliance with ICH-GCP (International Council for Harmonisation - Good Clinical Practice), FDA, EMA, and other regulatory guidelines.
At Clievi, we offer end-to-end clinical trial support services, assisting pharmaceutical companies, biotechnology firms, contract research organizations (CROs), and academic research institutions in optimizing clinical trial design, execution, and regulatory submissions. Our team of experts ensures high-quality, data-driven decision-making, accelerating trial efficiency and regulatory approvals.
Our Clinical Trial Support Services
1. Clinical Trial Design & Protocol Development
A well-structured clinical trial begins with a scientifically robust and regulatory-compliant protocol. We specialize in:
- Study Design Optimization: Choosing the appropriate trial design (randomized controlled trials [RCTs], adaptive trials, crossover studies, non-inferiority trials).
- Protocol Development: Drafting comprehensive protocols that meet ICH-GCP, FDA, EMA, and WHO clinical trial guidelines.
- Sample Size Calculation & Power Analysis: Ensuring adequate statistical power for meaningful results.
- Endpoint Selection & Biomarker Validation: Defining primary, secondary, and surrogate endpoints aligned with regulatory expectations.
- Ethical Considerations & IRB Submissions: Preparing ethics committee/IRB applications, ensuring informed consent compliance.
2. Regulatory Strategy & Submission Support
Navigating the regulatory landscape is critical for trial success. Our services include:
- Investigational New Drug (IND) & Clinical Trial Application (CTA) Submissions: Preparing regulatory dossiers for FDA, EMA, MHRA, PMDA, and other authorities.
- Clinical Trial Registration: Ensuring compliance with ClinicalTrials.gov, EU-CTR, and other registries.
- Regulatory Documentation & Compliance:
- Investigator’s Brochure (IB)
- Clinical Study Reports (CSRs)
- Risk-Based Monitoring Plans
- Adverse Event & Serious Adverse Event (SAE) Reporting
- Regulatory Authority Communication Support (FDA Pre-IND, EOP2, and Pre-NDA Meetings)
3. Site Selection & Investigator Support
The success of a clinical trial depends on efficient site selection and investigator engagement. Our services include:
- Feasibility Studies & Site Selection: Identifying high-performing sites with qualified investigators, patient availability, and regulatory compliance.
- Site Initiation & Training: Conducting investigator meetings, GCP training, and protocol adherence workshops.
- Clinical Trial Agreements (CTAs) & Budget Negotiations: Managing contractual agreements between sponsors, CROs, and study sites.
4. Patient Recruitment & Retention Strategies
Patient recruitment is a critical determinant of clinical trial timelines. We employ evidence-based recruitment strategies to ensure timely enrollment and retention, including:
- Targeted Patient Identification: Leveraging AI-driven feasibility studies, real-world data (RWD), and electronic health records (EHRs).
- Diversity & Inclusion Initiatives: Ensuring recruitment of underrepresented populations for regulatory compliance (e.g., FDA diversity mandates).
- Retention & Adherence Monitoring: Implementing patient engagement platforms, telehealth follow-ups, and compliance tracking.
5. Clinical Trial Monitoring & Risk-Based Quality Management
Our risk-based monitoring (RBM) approach ensures regulatory compliance, data integrity, and participant safety.
- On-Site & Remote Monitoring: Conducting source data verification (SDV), protocol deviation tracking, and compliance assessments.
- Data Safety Monitoring Board (DSMB) Support: Establishing independent DSMBs for interim safety reviews.
- Centralized Statistical Monitoring (CSM): Using AI-driven tools to detect anomalies, site-level discrepancies, and fraud risks.
6. Clinical Data Management & Biostatistical Analysis
Our end-to-end clinical data management (CDM) and biostatistical support ensure high-quality, regulatory-compliant data reporting.
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Data Management:
- Electronic Data Capture (EDC) system setup (Medidata RAVE, Oracle Clinical, REDCap).
- Data validation, coding (MedDRA, WHO-DD), and query resolution.
- SAE reconciliation, ensuring regulatory compliance.
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Biostatistical Analysis:
- Interim & Final Analysis: Kaplan-Meier survival curves, Cox proportional hazards modeling.
- Randomization & Blinding Strategies: Ensuring minimization of selection bias.
- Subgroup & Sensitivity Analyses: Evaluating treatment effects across diverse patient cohorts.
- Bayesian Adaptive Trial Designs & Machine Learning Models: Improving decision-making efficiency.
7. Clinical Study Report (CSR) & Medical Writing
We provide regulatory-compliant medical writing services, ensuring submission-ready documentation:
- Clinical Study Reports (CSRs) per ICH E3 Guidelines.
- Manuscripts & Scientific Publications for peer-reviewed journals.
- Regulatory Responses & Briefing Documents for FDA, EMA, and MHRA inquiries.
Why Choose Clievi for Clinical Trial Support?
- Comprehensive End-to-End Support: From study design to regulatory submissions and post-market analysis.
- Regulatory Compliance Expertise: Ensuring adherence to ICH-GCP, FDA, EMA, MHRA, and WHO guidelines.
- Cutting-Edge Data Management & Analytics: AI-powered real-world evidence (RWE), machine learning algorithms, and centralized monitoring solutions.
- Cost-Efficient & Time-Saving Approaches: Leveraging risk-based monitoring (RBM) and adaptive trial designs to reduce costs.
- Patient-Centric Recruitment Strategies: Ensuring diverse, representative, and timely patient enrollment.
Industries & Clients We Serve
- Pharmaceutical & Biotech Companies – Supporting Phase I-IV trials, orphan drug studies, and biosimilars.
- Academic & Clinical Research Institutions – Collaborating on investigator-initiated trials (IITs) and multi-center studies.
- Medical Device & Diagnostics Companies – Conducting pivotal and post-market surveillance trials.
- Regulatory & Government Agencies – Ensuring regulatory submissions and compliance with global health authorities.
Get in Touch – Accelerate Your Clinical Trial Success
Partner with Clievi to streamline clinical trial execution, regulatory compliance, and data integrity. Contact us today to discuss your clinical research needs.
Email:
Website: www.clievi.com