Clinical

Looking beyond borders and connecting all relevant sources on your behalf to accomplish innovative drug development concurrent with efficient planning to guarantee success.

Decisions Based On Evidence.

Excelling in clinical trial development and project management, our goal is to develop and effectuate complete clinical research projects, focusing on clinical pharmacology and providing you with translational insight.

Many new drug products in development are first-in-man clinical trials and/or even first-in-class treatments. Consequently, their clinical trial designs withhold very specific challenges ranging from the mode of delivery and inclusion/exclusion criteria to the selection of the appropriate starting dose and a strategy for patient enrolment.

Our track record shows our ability to deliver excellent study designs, protocols and reports, and our capability to function as dedicated liaisons for our clients. With access to the latest technologies, we combine our flexibility, experience, and strong teamwork to provide you with the best solutions.

Study Design – Intelligent Design That Gets Results

The clinical development process can be daunting. With its increasing complexity, risk, and compliance challenges, optimizing your study designs can save your organization significant time and money. Additionally, in your clinical trial designs, it’s pivotal to optimize protocol design to ensure reliable delivery of results and avoid amendments to your clinical development plan that can set back your timelines.

Our consultant apply a risk and data-driven approach in their clinical trial strategies to ensure the feasibility of your studies. By taking into account risk mitigation and contingency plans it’s possible to ensure that trials meet milestones and budget expectations.

Clinical Development Strategy – A Experienced Partner At The Table

Monitoring various regulatory submissions, ensuring manageable timelines, and working with the regulatory authorities to make sure you meet all your milestones and deadlines is a task of its own.

In addition to preparing and reviewing regulatory documents, our team is experienced in preparing the packages for meetings with regulatory agencies and acting as representation on your behalf. We have the inhouse experience to manage communication with both EMA and FDA as well as familiarity with the differences in local regulatory requirements in the EU; both on technical and regulatory issues.

PK/PD – Supporting Critical Go / No-Go Decisions

Our track record in predictive PK/PD modelling in clinical development can support your study design and dose selection and increase translational insights gained from your clinical studies. Early and late phase studies are within our scope and our team can perform both non-compartmental analyses and population PK/PD analyses across a broad array of therapeutic areas in clinical development.

We invite you make use of our experience and ability to leverage published data of existing compounds to gain an optimal understanding of exposure variability and treatment responses. Asking the right questions early on can help you optimize study designs for your subsequent clinical studies and tilt the scales at critical go / no-go decisions.

Project Management – From GAP Analysis To Full Project Management

There is no getting around the fact that clinical development is getting increasingly complex and there are ample challenges that can delay entire programs. Setbacks caused by regulatory requirements and compliance issues, difficulties in balancing patient and protocol needs, or simply the lack of expertise in project management skills are common hurdles in on-time delivery in clinical development.

Our communication skills, experience in designing efficient drug development plans, and critical gap-analyses have proven pivotal in creating solutions for our clients. Whether you are looking for start-to-finish stage project management or temporary provision of management skills, our team can offer you the focus and key tools to successfully formulate and execute effective business strategies. Our promise of effortless commitment and desire to deliver tailored solutions continuously results in exceeding our clients’ expectations. 

Clinical RA – Tailored Medical Writing From Protocol to Application

Navigating the landscape set by health authorities, brings about challenges in regulatory communication regarding strategy, scientific and medical understanding of a clinical development, sites, sponsors and so on. A scientific-mindset is a prerequisite in preparing clinical documents like protocols, clinical study reports, and Investigator Brochures.

Our medical writing capabilities and expertise throughout the clinical development process allow our team to develop accurate messaging for your various audiences. Whether it’s writing effective protocols, understandable informed consent forms or the applications for your clinical trials in the EU and US, we have an elaborate understanding of regulatory guidelines and deliver compliant materials.

Your regulatory, scientific, technical, medical, and post-marketing communications? We have it covered.

Study Design - Intelligent Design That Gets Results

The clinical development process can be daunting. With its increasing complexity, risk, and compliance challenges, optimizing your study designs can save your organization significant time and money. Additionally, in your clinical trial designs, it’s pivotal to optimize protocol design to ensure reliable delivery of results and avoid amendments to your clinical development plan that can set back your timelines.

Our consultant apply a risk and data-driven approach in their clinical trial strategies to ensure the feasibility of your studies. By taking into account risk mitigation and contingency plans it’s possible to ensure that trials meet milestones and budget expectations.

Clinical Development Strategy – A Experienced Partner At The Table

Monitoring various regulatory submissions, ensuring manageable timelines, and working with the regulatory authorities to make sure you meet all your milestones and deadlines is a task of its own.

In addition to preparing and reviewing regulatory documents, our team is experienced in preparing the packages for meetings with regulatory agencies and acting as representation on your behalf. We have the inhouse experience to manage communication with both EMA and FDA as well as familiarity with the differences in local regulatory requirements in the EU; both on technical and regulatory issues

PK/PD – Supporting Critical Go / No-Go Decisions

Our track record in predictive PK/PD modelling in clinical development can support your study design and dose selection and increase translational insights gained from your clinical studies. Early and late phase studies are within our scope and our team can perform both non-compartmental analyses and population PK/PD analyses across a broad array of therapeutic areas in clinical development.

We invite you make use of our experience and ability to leverage published data of existing compounds to gain an optimal understanding of exposure variability and treatment responses. Asking the right questions early on can help you optimize study designs for your subsequent clinical studies and tilt the scales at critical go / no-go decisions.

Project Management – From GAP Analysis To Full Project Management

There is no getting around the fact that clinical development is getting increasingly complex and there are ample challenges that can delay entire programs. Setbacks caused by regulatory requirements and compliance issues, difficulties in balancing patient and protocol needs, or simply the lack of expertise in project management skills are common hurdles in on-time delivery in clinical development.

Our communication skills, experience in designing efficient drug development plans, and critical gap-analyses have proven pivotal in creating solutions for our clients. Whether you are looking for start-to-finish stage project management or temporary provision of management skills, our team can offer you the focus and key tools to successfully formulate and execute effective business strategies. Our promise of effortless commitment and desire to deliver tailored solutions continuously results in exceeding our clients’ expectations. 

Clinical RA – Tailored Medical Writing From Protocol to Application

Navigating the landscape set by health authorities, brings about challenges in regulatory communication regarding strategy, scientific and medical understanding of a clinical development, sites, sponsors and so on. A scientific-mindset is a prerequisite in preparing clinical documents like protocols, clinical study reports, and Investigator Brochures.

Our medical writing capabilities and expertise throughout the clinical development process allow our team to develop accurate messaging for your various audiences. Whether it’s writing effective protocols, understandable informed consent forms or the applications for your clinical trials in the EU and US, we have an elaborate understanding of regulatory guidelines and deliver compliant materials.

Your regulatory, scientific, technical, medical, and post-marketing communications? We have it covered.

Inez de Greef - van der Sandt

Inez de Greef - van der Sandt

Inez is a pharmaceutical professional and advisor for different biotech companies and organizations. In addition, she has been CEO of Treeway since 2013, developing therapies for amyotrophic lateral sclerosis.

Interested?

Contact us for enquiries regarding our clinical expertise.

e info@3d-pxc.com
t +31 1 353 482 72

Maidstone 48a, 5026 SK Tilburg,
The Netherlands

Pivot Park, RK Building, room 2326,
Kloosterstraat 9,
5349 AB Oss,
The Netherlands

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