Find the nearest office SOLUTIONS EXPERTISE RESOURCES CONTACT CAREERS ABOUT NEIGHBORHOOD VCLS INNOVATION CENTER VCLS SOLUTIONS BY STAGE OF DRUG DEVELOPMENT LATE-STAGE CLINICAL DEVELOPMENT By Stage of Drug Development LATE-STAGE CLINICAL DEVELOPMENT Pre-Clinical Development Determine the safe dose for FIH study Early-Stage Clinical Development Assess efficacy, effectiveness and safety Late-Stage Clinical Development Gather data for registration and market access Registration Assemble and file an application Commercialization & Post-Launch Post-approval regulatory, lifecycle management Late-stage clinical development primarily aims at demonstrating efficacy, safety, and cost-effectiveness. It corresponds to Phases 2b and 3 confirmatory studies. The product is tested in larger clinical studies, often as compared with the therapeutic ‘gold standard’ or standard-of-care (SoC), if any. The collection of safety data on a larger scale enables the confirmation of the product’s safety profile. Phase 3 trials are conducted in a large number of countries in view of supporting approval in broader markets. Health economics data are also gathered to demonstrate the product’s value to payers and support post-approval reimbursement. CLIENT GOALS Design and conduct clinical trials Define clinical development strategy. Outline clinical development up to marketing, with for each trial. Generate required evidence for regulatory approval & market access (HTA, pricing & reimbursement) Develop clinical trial essential documents. Ensure regulatory compliance of clinical trials. CHALLENGES Is(are) the planned pivotal study(ies) adequate to support both registration and positive HTA appraisal? How to obtain endorsement from regulators and HTA on the late-stage clinical development strategy? How to measure health care resource use associated with the disease? How to articulate a development plan across multiple regions, with potentially different requirements? How to confirm/improve the product’s benefit/risk ratio? Which clinical endpoints would address both regulators’ and payers’ requirements? How can disease awareness be optimized? What must be done for launch readiness? How to validate manufacturing processes and methods? How to design/ adapt manufacturing for commercial launch (upscaling)? Which post-launch evidence will the payers require? Are there any early access opportunities? SOLUTIONS By Stage of Drug Development By Stage of Medical Device Development Product Expertise Industry Focused Therapeutic Areas Solutions for Switzerland Orphan Drugs VCLS COVID-19 Update PUBLICATION Orphan & Rare Disease Accelerating development, registration and access to medicines for rare diseases in the European Union through… Accelerating development, registration and access to medicines for rare diseases in the European Union through adaptive approaches: features and perspectives… OUR MISSION Voisin Consulting Life Sciences is the global reference partner to expedite access of HealthTech products to regulated markets. ADVANCE WITH US WHAT VCLS CAN DO Design the study documentation, conduct clinical trials and site management Establish clinical safety system Coordinate with all your clinical development partners to meet regulatory requirements Communicate with regulators and payers to understand HTA evidence requirements Plan HEOR evidence generation BACK TO TOP VCLS EXPERTISE Regulatory Strategy & Submissions Design and implementation of global patient-centric regulatory strategies to ensure expedited product… Chemistry, Manufacturing & Controls (CMC) Overcome regulatory, scientific and technical challenges ensuring compliance, flexibility on the production… Due Diligence VCLS assists investors and helps HealthTech product developers prepare for Due Diligences,… GET IN TOUCH --- Afghanistan Albania Algeria American Samoa Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Christmas Island Cocos (Keeling) Islands Colombia Comoros Congo Cook Islands Costa Rica Croatia Cuba Curaçao Cyprus Czech Republic Côte d'Ivoire Democratic Republic of the Congo Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See (Vatican City State) Honduras Hong Kong Hungary Iceland India Indonesia Iran Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati Kosovo Kuwait Kyrgyzstan Laos Latvia Lebanon Lesotho Liberia Libya Liechtenstein Lithuania Luxembourg Macau Macedonia, the former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Marshall Islands Martinique Mauritania Mauritius Mayotte Mexico Micronesia Moldova Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island North Korea Northern Mariana Islands Norway Oman Pakistan Palau Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Islands Poland Portugal Puerto Rico Qatar Rennes st Gregoire Romania Russian Federation Rwanda Réunion Saint Barthélémy Saint Helena, Ascension and Tristan da Cunha Saint Kitts and Nevis Saint Lucia Saint Martin (French part) Saint Pierre and Miquelon Saint Vincent and the Grenadines Samoa San Marino Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Sint Maarten (Dutch part) Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and the South Sandwich Islands South Korea South Sudan Spain Sri Lanka State of Palestine Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syria São Tomé and Príncipe Taiwan Tajikistan Tanzania Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu USA Minor Outlying Islands Uganda Ukraine United Arab Emirates United Kingdom United States Uruguay Uzbekistan Vanuatu Venezuela Vietnam Virgin Islands (British) Virgin Islands (USA) Wallis and Futuna Western Sahara Yemen Zambia Zimbabwe Select your country...* --- Search Engine Conference Referral Social Media (LinkedIn, Twitter) Webinar Neighborhood Event Neighborhood Website How did you hear about us ?* --- Biologic Drugs Cell, Gene and Tissue Therapy Chemical Drugs Classical Medical Device Combination Product Digital Medical Device E-Health/M-Health IVDs & CDx Microbiome-based Products Vaccines Other Product type...* *I have read and agreed to the Terms of Use and the Privacy Policy. Yes, I would like to receive communications regarding VCLS services and events SEND VCLS INSIGHTS Blog Events Presentations Publications Whitepapers Webinars ABOUT Who We Are What We Do Team Jobs Life at VCLS Neighborhood VCLS © 1997 - 2021 - ALL RIGHTS RESERVED SITE MAP PRIVACY POLICY TERMS OF USE FOLLOW US ON SOCIAL MEDIA