Frequently Asked Questions
Below you’ll find answers to some of the most frequently asked questions at Mprex. We are adding the most asked question to this page so if you have a question and don’t see your answer, don’t hesitate to email us at clinicalresearch@mprex.in
The budget for a clinical trial can vary significantly based on several factors, including:
1. Treatment duration
2. Sample size
3. Parameters to be evaluated
4. Study groups
5. Study designs
For a personalized discussion regarding the budget for your clinical trial project, we invite you to schedule a meeting with our team. Click the link below to arrange a consultation and explore how we can optimize your trial budget while meeting your research objectives.
Steps in Conducting Clinical Trials
- Briefing from the sponsor regarding trial requirements
- Development of synopsis and clinical trial budget
- Sponsor agreements and Clinical Trial Agreements (CTA)
- Shortlists Study Sites from the database
- Site feasibility visit (Investigator discussion of the Study Synopsis, enrollment strategy, Patient Pool, Referral Activities, and other Logistics)
- Collate and Compile site responses into a Site Feasibility Grid
- Grade and prioritize selected sites
- Including study specific Projections, Timelines, and Risk Evaluation and Mitigation Strategy
- Keeping the client updated and taking consent
- Completion of essential documents/dossier for submission to the EC and Regulatory (if applicable)
- EC and Regulatory (if applicable) Submission and Seeking Permission
- CTRI and other Portal Registration
- Site initiation visit
- Enrolments and Follow-Ups (Data Entry with QC/QA)
- Trial monitoring and audits
- Regular Client Updates
- Communications with the ECs, Regulatory, Investigator and Client
- Clinical data management and statistical analysis
- Clinical Study Report (Interim reports if applicable)
- Manuscript/White paper and communication to scientific journals
The duration of a clinical trial can vary widely depending on several factors, including:
1. Study Phase
2. Complexity of the Study
3. Recruitment and Enrollment
4. Follow-Up Period
5. Regulatory Approval Process
6. Data Analysis and Reporting
While some clinical trials may be completed within a few months, others, particularly large-scale trials or those involving rare diseases, may take more time. It’s essential to consider these factors when planning and budgeting for a clinical trial.
We offer a comprehensive range of services including protocol development, site selection, patient recruitment, regulatory compliance, data management, monitoring, and reporting.
Our team comprises experienced professionals with expertise in various therapeutic areas and extensive experience in managing and conducting clinical trials according to international standards and regulations.
Patient safety is our top priority. We adhere strictly to ethical principles an regulatory guidelines, conduct thorough risk assessments, implement robust safety monitoring procedures, and provide appropriate training to all staff involved.
We employ a targeted and multi-faceted approach to patient recruitment, utilizing various channels including social media, patient databases, healthcare providers, and community outreach programs to ensure timely enrollment of suitable participants.
We implement stringent quality control measures throughout the trial process, including data validation checks, source document verification, and regular monitoring visits to ensure data accuracy, completeness, and integrity.
We have a proven track record of successfully meeting project timelines and budgets, thanks to our efficient project management practices, proactive risk management, and flexible resource allocation strategies.
Yes, we provide comprehensive support for regulatory submissions and approvals, including preparation of regulatory documents, interactions with regulatory authorities, and compliance with local and international regulations.
We adhere strictly to ethical principles and regulatory requirements, including Good Clinical Practice (GCP) guidelines, ensuring that all aspects of the trial are conducted ethically and in accordance with applicable laws and regulations.
Yes, we offer post-trial support services including data analysis, interpretation of results, preparation of final reports, and assistance with manuscript writing and publication.
Our CRO stands out for its commitment to excellence, scientific rigor, flexibility, and client-centric approach. We prioritize building long-term partnerships with our clients and strive to deliver exceptional results with every project.