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Pre-IND and Trial Support: Accelerate Your Clinical Journey With CliniExperts
Build a strong regulatory foundation with comprehensive Pre-IND planning and end-to-end clinical trial support with us. We'll help you navigate FDA expectations with confidence and reduce the risk of delays or non-compliance.
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What Are Pre-IND and Trial Support?
Pre-IND (Investigational New Drug) and Clinical Trial Support involves strategic, regulatory, and operational guidance provided to drug developers, from initial drug development plans to clinical trials, ensuring a successful IND application and clinical trial conduct.
The Pre-IND phase includes pre-IND meetings with the FDA to clarify requirements, design preclinical and clinical studies, and address potential issues before submitting an IND. Clinical Trial Support includes assistance with designing protocols for Phase 1, 2, and 3 studies, managing submissions, and ensuring compliance with FDA and GCP requirements throughout all phases of clinical research.
Why Are Pre-IND and Trial Support Important?
Improved IND Submission
Pre-IND meetings with the FDA provide early feedback, which helps drug developers or sponsors refine their development plans proactively before formal submission.
Reduced Risk of Clinical Holds
Addressing potential issues and preparing for a complete IND application potentially prevents costly delays or clinical holds.
Quick Approvals
Streamlining the clinical strategy with FDA regulatory expectations increases acceptance rates, thus ensuring pre-IND and clinical trial support contribute to bringing new therapies to patients more quickly.
Ensure Compliance
During early-phase trials or documentation preparation for market approval, ensuring trials are compliant with FDA Good Clinical Practices (GCP) and other federal guidelines is essential for adherence to regulatory requirements.
Ethical and Scientific Integrity
Clinical trial support ensures that studies are conducted ethically and scientifically, ensuring the safety and rights of participants and providing robust data for regulatory.
Process Flow for Pre-IND and Trial Support
Regulatory Gap Assessment
Pre-IND Meeting Request and Briefing Package Development
FDA Meeting Conduct and Feedback Analysis
IND Application Preparation (CMC, Nonclinical, Clinical Modules)
IND Submission and Acknowledgment
Clinical Protocol Development and Submission (Initial and Amendments)
Ongoing FDA Communication and Trial Monitoring Support
How Can We Help in Pre-IND and Trial Support?
Choose to appoint CliniExperts as your trusted partner for comprehensive compliance solutions.
Pre-IND Meetings: Early interaction with the FDA can significantly influence the success of your clinical development program. We help you prepare for pre-IND meetings, where we’ll discuss trial design, endpoints, data requirements, and specific questions regarding your drug or biologic.
Clinical Trial Authorization (CTA): We prepare and submit your IND application to gain FDA approval for human clinical trials. Our team ensures that your submission is comprehensive and adheres to all regulatory requirements for clinical trial initiation.
Phase I-IV Support: Whether you’re conducting early-phase trials or preparing for market approval, we ensure your trials are compliant with FDA Good Clinical Practices (GCP) and other federal guidelines.
Clinical Study Monitoring and Reporting: We provide ongoing monitoring of clinical studies to ensure they adhere to regulatory requirements, and we assist with reporting findings to the FDA and other stakeholders as needed.
Services
| Service | Details |
|---|---|
| Pre-IND Strategy and Meeting Support |
|
| IND Submission Support |
|
| Clinical Trial Design and Execution |
|
| Regulatory Communication |
|
Regulatory Requirements for Pre-IND and Trial Support
Documents
Pre-IND Meeting Request Letter – Briefing Document (including preclinical data, proposed study design, questions to FDA) – IND Application Modules (1-5) – Clinical Protocol – Investigator’s Brochure – Informed Consent Form (ICF)
Timeline
Pre-IND Meeting: ~60 days from request to meeting – IND Review: FDA typically responds within 30 days after IND submission
Regulatory Body
U.S. Food and Drug Administration (FDA), CDER or CBER
Fees
No FDA fee for Pre-IND meetings or IND submissions; Sponsor may incur internal costs (e.g., CRO, consulting, submission costs)
Validity
IND remains active unless withdrawn, terminated, or placed on hold by FDA – Clinical trial protocols and IND must be kept current via amendments and annual reports
Frequently Asked Questions(FAQs)
How much time does it take for the FDA to acknowledge the pre-IND meeting request?
Once the FDA accepts the request, the FDA will respond within 21 days of receiving the meeting request, and meetings are generally scheduled within 60 days of the request. Sponsors can therefore submit their request approximately two months before they would like to have the pre-IND meeting.
What essential information should be included in the pre-IND meeting request?
The following information ensures successful outcome of a pre-IND meeting:
- Meeting objective
- Proposed agenda, including estimated times needed for each agenda item
- Listing of specific questions categorized and grouped by discipline, for example, chemistry, manufacturing, and controls (CMC), pharmacology/toxicology, clinical pharmacology and biopharmaceutics, and clinical investigations
- List of sponsor participants
- List of requested participants from CDER
- Quantitative composition (all ingredients by percent composition) of the drug proposed for use in the study to be discussed
- Proposed indication
- Dosing regimen, including concentration, amount dosed, and frequency and duration of dosing if known
- Proposed meeting date (propose 6-8 weeks in the future)
- When the background packet will be available (at least 4 weeks before the proposed meeting date)
Are there recurrent problems at pre-IND meetings?
The following have been identified as recurrent issues in pre-IND meetings:
- Inadequate CMC information
- Insufficient pre-clinical support
- Unacceptable clinical trial design
- Noncompliance with Good Clinical Practices (GCPs)
- Lack of information on selection of dosage
What do you include in a pre-IND meeting packet?
- Overall program synopsis
- Whether the animal efficacy rule is being considered
- Clinical study synopsis to obtain FDA input on inclusion, exclusion, and endpoints
- Results for in vitro and early in vivo toxicology
- Rationale for safety, based on toxicological profile and safety margin using dose regimen and exposure
- Brief description of the manufacturing scheme for the active pharmaceutical ingredient (API) and formulation for clinical study
- Brief assay descriptions
- Full description of the development plan
- Copy of the meeting request with updates to reflect the most current information
