№ lp_2_1_13350
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Submission form for unsolicited clinical study concepts requesting product support and sponsorship for investigator-initiated clinical trials, including regulatory compliance disclosures and institutional authorization requirements.
Organization:
Napo Pharmaceuticals
Document Type:
Clinical concept proposal submission form
Purpose:
Request for product support and sponsorship of Investigator-Initiated Trials
Target Applicants:
Independent Investigators
Therapeutic Scope:
Clinical research across therapeutic areas
Regulatory References:
U.S. Food and Drug Administration (FDA)
Submission Method:
Email submission to [email protected]
Required Documentation:
Curriculum Vitae and list of publications
Legal Notice:
Support subject to separate written legal agreement and company discretion
Clinical Information Required:
Study design, endpoints, eligibility criteria, enrollment timeline, investigational product details
Compliance Disclosure:
History of FDA inspections, Form 483 records, governmental investigations, and facility storage capabilities
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2018
Region / City:
Melbourne
Subject:
Clinical Trials, Monitoring, Investigator-Initiated Trials
Document Type:
Template
Organization / Institution:
Melbourne Children’s Trials Centre, Clinical Research Development Office (CRDO)
Author:
Not specified
Target Audience:
Sponsor-Investigators, Clinical Research Professionals
Effective Period:
Not specified
Approval Date:
01 May 2018
Date of Changes:
Not specified
Year:
2026
Institution:
UVM Cancer Center
Document type:
Data & Safety Monitoring Plan
Target audience:
Principal Investigators, Study Teams
Study type:
Clinical trial / Observational study
Scope:
Investigator-initiated trials (IITs)
Approval body:
Protocol Review and Monitoring Committee (PRMC)
Monitoring committee:
Data Safety and Monitoring Committee (DSMC)
Risk assessment:
Based on study-specific risk level
Sections included:
Safety monitoring, adverse events, stopping rules, unblinding criteria, incidental findings
Guidance:
Section A - DSMP development instructions; Section B - PRMC-required form
Compliance:
Federal regulations, IRB reporting requirements
Context:
A formal study-specific plan detailing monitoring procedures, safety assessments, reporting protocols, and risk management for investigator-initiated cancer trials, intended as an official submission to institutional review committees.
Year:
2025
Region / city:
Global
Topic:
Pharmaceuticals, Quality Guidelines
Document Type:
Guideline
Organization / Institution:
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
Author:
ICH Assembly
Target Audience:
Regulatory authorities, pharmaceutical industry
Period of validity:
Ongoing
Approval Date:
14 May 2025
Date of Changes:
Currently under public consultation
Note:
Context
Year:
2023
Region / City:
Australia
Subject:
Chronic migraine, medicinal product submission
Document type:
Submission for PBS listing
Organization:
Novartis Pharmaceuticals Australia Pty. Limited
Author:
Not specified
Target audience:
Health professionals, pharmaceutical regulatory bodies
Period of validity:
Not specified
Date of approval:
2 July 2018
Date of amendments:
November 2023
Year:
2023
Region / city:
Australia
Topic:
Vedolizumab submission for chronic pouchitis treatment
Document type:
Submission for listing of medicinal product
Agency:
Therapeutic Goods Administration (TGA)
Author:
Takeda Pharmaceuticals Australia Pty. Ltd.
Target audience:
Healthcare professionals, regulatory authorities
Effective period:
From 29 June 2023
Approval date:
29 June 2023
Modification date:
N/A
Year:
2022
Region / city:
Sri Lanka
Topic:
Pharmaceuticals import
Document type:
Invitation for expressions of interest
Organization:
Ministry of Health, Sri Lanka
Author:
Ministry of Health
Target audience:
Pharmaceutical suppliers
Period of validity:
3 months
Approval date:
27th September 2022
Date of amendments:
N/A
Year:
2018
Region / City:
Australia
Topic:
Pharmaceutical Submission, Cancer Treatment
Document Type:
Submission
Organization / Institution:
Takeda Pharmaceuticals Australia Pty Ltd
Author:
Takeda Pharmaceuticals Australia Pty Ltd
Target Audience:
Healthcare professionals, PBAC
Period of Validity:
Ongoing
Approval Date:
23 May 2018
Date of Amendments:
Not specified
Year:
2017
Region / City:
United States
Theme:
Public Law, Pharmaceutical Pricing
Document Type:
Request for Modification
Organization / Institution:
U.S. Department of Veterans Affairs
Author:
Not specified
Target Audience:
Contractors in the pharmaceutical and medical supply industry
Effective Period:
January 15, 2017 or later
Approval Date:
November 2016
Amendment Date:
November 2016
Context:
A regulatory document outlining the procedures for modifying contracts related to pharmaceutical pricing under Public Law 102-585.
Year:
2025
Region / city:
Global
Subject:
Pharmaceutical Registration
Document Type:
Guideline
Author:
International Council for Harmonisation (ICH)
Target audience:
Regulatory authorities, pharmaceutical companies
Period of validity:
Not specified
Approval date:
14 May 2025
Date of changes:
Not specified
Year:
2024
Region / City:
Ratmalana, Sri Lanka
Subject:
Supply, Installation, and Commissioning of Inline Checkweigher Systems
Document Type:
Tender Document
Organ / Institution:
State Pharmaceuticals Manufacturing Corporation (SPMC)
Author:
State Pharmaceuticals Manufacturing Corporation
Target Audience:
Bidders for the supply and installation of checkweigher systems
Period of Action:
September 2024
Approval Date:
2024
Modification Date:
N/A
Year:
2021
Region / City:
Australia
Topic:
Pharmaceutical submission
Document type:
Submission report
Organization:
Novartis Pharmaceuticals Australia Pty Limited
Author:
Novartis Pharmaceuticals Australia Pty Limited
Target audience:
Healthcare professionals, regulatory bodies
Period of validity:
Ongoing
Approval date:
21 August 2002
Date of revisions:
18 December 2009, 11 March 2016, 8 July 2021, 16 July 2021, 29 July 2021
Note:
Contextual description
Year:
2021
Region / City:
Madison, WI
Subject:
Ethnobotany, Biopiracy, Gender and Race Studies
Document Type:
Syllabus
Institution:
University of Wisconsin-Madison
Author:
Ruth Goldstein, PhD
Target Audience:
Undergraduate and Graduate students
Period of Validity:
Fall Semester
Approval Date:
2021
Date of Changes:
Not specified
Year:
2021
Region / City:
Global
Subject:
Procurement
Document Type:
Bidding Document
Organization:
The World Bank
Author:
The World Bank
Target Audience:
Bidders, Contractors, Procurement Officers
Period of Validity:
N/A
Approval Date:
June 2021
Date of Changes:
June 2021
Year:
2020
Region / City:
Australia
Theme:
Pharmaceutical submission, medical treatment
Document Type:
Submission
Organization / Institution:
Takeda Pharmaceuticals Australia Pty Ltd
Author:
Takeda Pharmaceuticals Australia Pty Ltd
Target Audience:
Medical practitioners, gastroenterologists
Period of Validity:
Not specified
Approval Date:
12 May 2020
Modification Date:
Not specified
Registration Status:
Registered by TGA
Clinical Claim:
VDZ SC is as effective as VDZ IV for maintenance treatment in MSUC and severe CD
Indications:
Treatment for moderate to severe ulcerative colitis and Crohn’s disease
Requested Listings:
PBS listing for VDZ SC as maintenance treatment
Prescriber Instructions:
Specific guidelines for initiating subcutaneous therapy
Administrative Advice:
Applications for authorisation under PBS can be made online or by phone
Contextual Description:
A pharmaceutical submission for the approval of vedolizumab (VDZ SC) as a maintenance treatment for moderate to severe ulcerative colitis and severe Crohn’s disease based on a cost-minimisation analysis.
Year:
2017
Sector:
Health
Goods covered:
Pharmaceuticals, Vaccines, Condoms
Document type:
Standard Procurement Document
Procurement stage:
Prequalification
Procurement method:
Request for Bids
Issuing organization:
World Bank
Applicable regulations:
Procurement Regulations for IPF Borrowers
Financing sources:
IBRD, IDA
Initial issue:
July 2016
Revision dates:
July 2016; January 2017; October 2017
Geographic applicability:
World Bank-financed projects
Legal framework reference:
Procurement Regulations for IPF Borrowers, July 2016 as amended
Intended users:
Borrowers and implementing agencies
Copyright status:
Copyrighted; non-commercial use only
Year:
2016
Region / city:
Australia
Theme:
Paediatric-onset Hypophosphatasia (HPP) treatment
Document type:
Application submission
Organ / institution:
Alexion Pharmaceuticals Australasia Pty Ltd
Author:
Alexion Pharmaceuticals Australasia Pty Ltd
Target audience:
Healthcare professionals, Pharmaceutical regulatory bodies
Period of validity:
Ongoing
Approval date:
14 January 2016
Date of amendments:
N/A
Year:
2004
Region / City:
Accra, Ghana
Topic:
Public procurement, healthcare
Document Type:
Tender Document
Organization / Institution:
Public Procurement Board
Author:
Public Procurement Board
Target Audience:
Procurement entities, tenderers
Validity Period:
N/A
Approval Date:
March 2004
Date of Amendments:
N/A