🚀 Exciting News for Drug Developers! The FDA has published draft guidance on a Platform Technology Designation Program that outlines how drug sponsors can leverage platform technologies to produce multiple drugs or biological items using a standardized manufacturing process. Eligibility, benefits, data leverage, and submission guidelines are addressed. Don't miss out—submit your comments by July 29, 2024! 📅 Read more > https://hubs.li/Q02J9q2-0 #biotech #biopharma
About us
Veristat is the science-first full-service drug and biologic CRO and consultancy that integrates strategic planning, regulatory expertise, and clinical trial execution to rapidly advance the most complex or novel therapies. At Veristat, we collaborate with clients to support the rapid delivery of life-changing therapies, helping them make sound decisions amidst uncertainties. Our scientific experts design and conduct the global activities required for any clinical, regulatory, or commercialization program comprehensively and efficiently. With our focus on novel drug development and nearly 30 years of experience, our versatile approach and bold scientific thinking make the impossible possible. Depend on our game-changing expertise and reliable execution for fast results and positive impact to support your biologics and drugs to treat rare cancers, CNS/Neurological disorders, Endocrine/metabolic disorders, and infectious diseases. We are…Bold. Scientific. Versatile. Veristat. - Veristat has recently been made aware that unknown third parties that have no connection to Veristat are generating fake Veristat job postings, interviews, and even fake employment offers via emails, websites, and various social media platforms, seemingly for the purpose of fraudulently obtaining personal information from legitimate job candidates. All legitimate correspondence from Veristat will originate from our applicant tracking system (Jobvite) or an @veristat.com email address. If you have received outreach from someone claiming to be a member of our team please search our official LinkedIn company page (https://www.linkedin.com/company/veristat-llc), where all members of our authorized recruiting team can be identified, or contact us directly at talentacquisition@veristat.com. Be vigilant.
- Website
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http://www.veristat.com
External link for Veristat
- Industry
- Research Services
- Company size
- 501-1,000 employees
- Headquarters
- Southborough, Massachusetts
- Type
- Privately Held
- Specialties
- Strategic Consulting, Safety Management, Data Management, Biostatistics, Statistical Programming, Project Management, Medical Writing, Regulatory Submissions, Adaptive Clinical Trial Design, Site Monitoring, Regulatory Consulting, Clinical Trial Patient Recruitment, Clinical Trial Data Standardization, Clinicl Trial Design, Clinical Trial Management, US Regulatory Agent, Pharmacovigilance, Marketing Applications Support, IND Support, Regulatory Publishing, Biologic, Gene Therapy, Full-service CRO, and Oncology Clinical Trials
Locations
Employees at Veristat
Updates
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Transforming data into decisions! At Veristat, our enhanced reporting standards for DMC Services mean complex trial data is now more accessible and actionable than ever. See how we're setting new benchmarks in statistical reporting > https://hubs.li/Q02Hf3lb0 #DataInsights #biotech #clinicaltrials
Data Monitoring Committees in Clinical Trials - DMC, CEC, DSMB | Veristat
veristat.com
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The European Commission announced call for proposals for EU action grants in the area of crisis preparedness, under the EU4Health Annual Work Programme 2024, including calls for: 👉 The European Hub for vaccine development 👉 Next-generation respiratory protection 👉 Innovative manufacturing technologies/processes in the Union for medicines production 👉 The development of novel antivirals The deadline for applicants is 5 September 2024 > https://hubs.li/Q02HtD4g0 #EU4Health #Pharma
EU4Health 2024 calls for proposals
hadea.ec.europa.eu
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🎧 Hear our CSO, Cindy Henderson explain Veristat's comprehensive, end-to-end solutions for marketing applications. Watch now 📽️ https://hubs.li/Q02Htxz20 #VeristatYouTube #MarketingApplications #biotech
Marketing Applications: An End-to-End Solution
https://www.youtube.com/
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The German Parliament Bundestag adopted the revised Medical Research Act. The legislation among other aspects, will: ➡ Facilitate the implementation of decentralized clinical trials ➡ Create a legal basis for the publication of standard contractual clauses for trials ➡ Accelerate the conduct of mono-national clinical trials ➡ Task a specialized ethics committed in charge of special procedures at federal level ➡ Limit price confidentiality to pharmaceutical companies with research departments located in Germany ➡ Hold price negotiations first, then give manufacturers incentives to select whether the price should be confidential or public 🔗https://hubs.li/Q02HtFrg0 #EU #clinicalresearch #clinicaltrials
Germany Adopts Revised Medical Research Act
bundestag.de
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With continued staffing reductions in Biopharma – will they have the right talent resourcing strategies in place to hit clinical trial milestones? Our latest blog shows how strategic FSP resourcing can help Biotech firms navigate talent shortages, meet milestones, and achieve clinical trial success. Read Now > https://hubs.li/Q02HtRFD0 #biopharma #biotech #clinicaltrials
FSP/Resourcing: Meeting the Moment with Expert Resources
veristat.com
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The Euresearch announced the launch of the European Research Council (ERC)'s Synergy Grants. The funding program is: 📌 Open to researchers based in Switzerland 📌 Endowed with a budget of €10 million 📌 Focused on any field of research 📌 Seeking public or private applicants A fact sheet detailing further conditions was made available. Swiss applications to the Synergy Grant can be submitted until 15 October 2024. Applicants located in the EU can apply until 6 November 2024. Euresearch fact sheet > https://hubs.li/Q02HtMgP0 ECR Synergy Grant > https://hubs.li/Q02HtKZz0 #SynergyGrants
ERC Synergy Grants open to participants in Switzerland
euresearch.ch
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Early access programs (EAPs) provide patients suffering with life-threatening diseases the chance to gain access to an investigational product for treatment outside of clinical trials when no other therapeutic options are available. To learn how to secure early access and reimbursement for your product, get in touch today > https://hubs.li/Q02Hf2Sl0 #biotech #patients
Commericalization - Market Access and Reimbursement | Veristat
veristat.com
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The European Commission released the report on critical medicines supply chains of the Health Emergency Preparedness and Response Authority (HERA). The EU Commission/HERA launched the Critical Medicines Alliance to address shortages of critical medicines earlier this year. The report investigated the supply chains of 11 medicines from the Union list of critical medicines. Recommendations include: ➡ Diversifying supply sources ➡ Enhancing production capacity ➡ Developing risk management frameworks 🔗 https://hubs.li/Q02HtMCd0 #pharmaceutical #healthcare
HERA Report on Critical Medicines Supply Chains
health.ec.europa.eu
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📣It's here! The latest addition of the monthly FDA Guidance and Regulatory News Review. Get an insight into the FDA final and draft guidance as well as the monthly approvals > https://hubs.li/Q02Hf2T90 #FDA #Regulatory
Monthly FDA Guidance and Regulatory News Review - June 2024
veristat.com