Development
Plan
Therapeutic Expertise
Phase I
Phase II-III
Regulatory
Submission
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Post-LAUNCH
Studies
DEVELOPMENT PLAN
A comprehensive clinical development plan will provide a roadmap for key activities – including cost and timeline factors – for investors and key stakeholders. We can help you understand your product's specific landscape and market, so you can develop a strategy that will effectively translate into trial execution – avoiding costly amendments down the road.
PHASE I
Establishing a collaborative, trusting, and transparent working relationship from the start is one of our primary objectives when working with customers in Phase I studies. To achieve that goal, we listen to your needs and pull together a project team with both early clinical development expertise and the therapeutic and indication-level expertise and scientific knowledge necessary to help navigate through the regulatory and clinical development process of a first-in-human study.
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Phase I
Phase II-III
Remove the complexity in getting to your next milestone. Our therapeutically aligned project teams receive specialized training on the unique needs of our biotech customers and follow customized SOPs. Each dedicated project lead also has industry-leading data, analytics, technology and expertise at their fingertips, and the knowledge to know how, and when, to pull in those resources to help our customers develop innovative solutions to complex problems.
Phase II-III
REGULATORY SUBMISSION
Regulatory
Submission
Tap into our extensive regulatory expertise to confidently interact with regulatory authorities around the world. Offering both operational and strategic consulting services, we work with you to develop smart and efficient regulatory strategies followed by effective regulatory submissions. Our teams of medical writers, biostatisticians, regulatory specialists and subject matter experts work together to deliver faster, more efficient submissions worldwide.
Learn more
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POST-LAUNCH
Studies
POST-LAUNCH Studies
Regulatory authorities are now increasing opportunities for you to provide real-world evidence of your products’ safety and effectiveness. This changing environment can make your products more available to patients. Increase the effectiveness and efficiency of your safety studies. Leverage our innovative methods for RWE study design and execution, combining secondary and primary data directly from patients and physicians.
Learn more
Learn more
THERAPEUTIC EXPERTISE
Therapeutic Expertise
You need a team that understands the nuances of your therapeutic area and indication. We have a deep bench of therapeutic experts who deliver valuable scientific insights on the clinical and commercial landscape for your therapeutic area. Our experienced study teams know what to expect and how to help you reach success.
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CONTACT US
Development
Plan
Phase I
Phase II–III
Regulatory
Submission
Post-launch
Studies
CONTACT US
Therapeutic
Expertise
DEVELOPMENT PLAN
A comprehensive clinical development plan will provide a roadmap for key activities – including cost and timeline factors – for investors and key stakeholders. We can help you understand the specific landscape and market for your product,
so you can develop a strategy that will effectively translate into trial execution – avoiding costly amendments down the road.
Learn more
PHASE I
Establishing a collaborative, trusting, and transparent working relationship from the start is one of our primary objectives when working with customers in Phase I studies. To achieve that goal, we listen to your needs and pull together a project team that has both early clinical development expertise and the therapeutic and indication-level expertise and scientific knowledge necessary to help navigate through the regulatory and clinical development process of a first-in-human study.
Learn more
Phase II-III
Remove the complexity in getting to your next milestone. Our therapeutically-aligned project teams receive specialized training on the unique needs of our biotech customers and follow customized SOPs. Each dedicated project lead also has industry-leading data, analytics, technology and expertise at their fingertips, and the knowledge to know how, and when, to pull in those resources to help our customers develop innovative solutions to complex problems.
Learn more
REGULATORY SUBMISSION
Tap into our extensive regulatory expertise to confidently interact with regulatory authorities around the world. Offering both operational and strategic consulting services, we work with you to develop smart and efficient regulatory strategies followed by effective regulatory submissions. Our teams of medical writers, biostatisticians, regulatory specialists and subject matter experts work together to deliver faster, more efficient submissions worldwide.
Learn more
POST-launch STUDIES
Regulatory authorities are now increasing opportunities for you to provide real-world evidence of your products’ safety and effectiveness. This changing environment can make your products more available to patients. Increase the effectiveness and efficiency of your safety studies. Leverage our innovative methods for RWE study design and execution, combining secondary and primary data directly from patients and physicians.
Learn more
THERAPEUTIC EXPERTISE
Looking for shared passion and a team that’s been there before? IQVIA delivers, through a deep bench of therapeutic experts who also deliver valuable insights on the clinical and commercial landscape for your disease area. Our experienced study teams know what to expect and how to help you reach success.
Powered by the IQVIA CORE
Through the interconnected capabilities of the IQVIA CORE, our scientific and operational teams can bring your clinical development program into the next generation. Real world insights are integrated throughout design and delivery to achieve new levels of precision, efficiency, and predictability.
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CONTACT US
Explore our services
Development
Plan
Therapeutic Expertise
POST-LAUNCH
Studies
Regulatory
Submission
Development
Plan
Phase II-III
Phase I