National Institute of Clinical Research’s Clinical Trial Consulting division is an innovative, international drug and device development organization that delivers the full spectrum of consulting from bench to commercialization.

Clinical Trial Consulting focuses on helping life-changing therapies succeed in various populations. The team’s therapeutic approach provides pharmaceutical, biotechnology, and start-up firms with an expertise in clinical trials composed of a unique mix of specialists from the following fields: academic, medical industry, nephrology, endocrinology, hematology, and cardiology.

To strengthen the success potential of your program, Clinical Trial Consulting excels in providing flexible study designs to accelerate development programs that deliver high approval ratings, exceptional global project management, a gold standard in safety, and data management systems.

For Investigators

Contract reviewing/preparation

• Confidentiality agreements
• Clinical Trial Agreements
• Review of proposed budget addendum
•  Negotiate on behalf of client with CRO/sponsor/SMO

• Staff employment/independent contractor contracts
• Dispute resolution

Regulatory advising

• SOP’s
• Audit preparedness evaluation
• Routine regulatory “maintenance” (training logs, 1572’s, etc.)
• Pre-FDA audit preparation
• Post-FDA audit advising

For CRO’s

Contract review/preparation

• Confidentiality agreements
• Clinical Trial Agreements and Master Services Agreements/work orders
•  Review of proposed clinical trial agreement budget addendum
•  Negotiate on behalf of client with vendors, sites

• Contract management
• Staff employment/independent contractor contracts
• Vendor agreements (e.g. radiology centers, labs)
• Dispute resolution

Regulatory Consulting

• Quality Systems, SOP’s, vendor evaluations
• Audit preparedness evaluation
• Routine regulatory “maintenance” (training logs, 1572’s, etc.)
• IRB submissions
• Pre-FDA audit preparation
• Post-FDA audit advising

For SMO’s

Contract review/preparation

• Confidentiality agreements
• Clinical Trial Agreements and Master Services Agreements/work orders(e.g. with hospitals)
• Review of proposed budget addendum
• Negotiate on behalf of client with vendors, PI’s

• Staff employment/independent contractor contracts
• Vendor agreements (e.g. radiology centers, labs)
• Dispute resolution

Regulatory advising services

• SOP’s
• Audit preparedness evaluation
• Routine regulatory “maintenance” (training logs, 1572’s, etc.)
• IRB submissions
• Pre-FDA audit preparation
• Post-FDA audit advising

For Academic Institutions

Contract review/preparation

• Confidentiality agreements
• Clinical Trial Agreements and Master Services Agreements/work orders (e.g. with sponsors/CRO’s)
• Review of proposed budget addendum
• Negotiate on behalf of client with vendors, PI’s

• Staff employment/independent contractor contracts
• Vendor agreements (e.g. radiology centers, labs)
• Dispute resolution

​Regulatory advising services

• SOP’s
• Audit preparedness evaluation
• Routine regulatory “maintenance” (training logs, 1572’s, etc.)
• IRB submissions
• Pre-FDA audit preparation
• Post-FDA audit advising

For Hospitals

Contract review/preparation

• Confidentiality agreements
• Clinical Trial Agreements and Master Services Agreements/work orders (e.g. with sponsors/CRO’s)
• Review of proposed clinical trial agreement budget addendum
• 2.Negotiate on behalf of client with vendors, PI’s
• Dispute resolution

Regulatory advising services

• SOP’s
• Audit preparedness evaluation
• Routine regulatory “maintenance” (training logs, 1572’s, etc.)
• IRB submissions
• Pre-FDA audit preparation
• Post-FDA audit advising