From the early phases of drug development through marketing authorisation, efficient and effective regulatory interactions are essential to your progress and success. These exchanges will not only shape the advancement of your program but also the value of your asset and company. Therefore, it...
The European Clinical Trials Regulation (Regulation (EU) No 536/2014) on clinical trials on medicinal products for human use requires that for all clinical trials carried out in the EU, a sponsor or a legal representative of the sponsor must be legally registered within the...
Venn Data Management services/capabilities span the data life cycle from collection to archival. Data drives the whole clinical development process. A high-quality dataset is therefore essential for the success of your drug. Our clinical data managers provide a smooth less flow from first patient...
By offering tailor made solutions with a strong focus on accuracy and quality, our clients can keep a track on timelines and costs are kept to a minimum. Our statisticians provide statistical support along the full development cycle of the drug, from early development...
To appropriately manufacture a pharmaceutical or biological product, a well-defined drug substance and product, manufacturing process and test methods must be developed in order to ensure that the product is safe, effective and consistent between batches. Which is a prerequisite to get regulatory approval...
From the early phases of development through marketing authorisation, regulatory interactions are essential to your progress and success. These exchanges will not only shape the advancement of your program, but also the value of your asset and your company. When you are planning your...
The success of drug development programmes depends on the accuracy, readability, and reviewer-friendliness of the documentation. Our team of seasoned medical writers, all of whom have a scientific or medical background, are at your disposal. With a broad experience in the development of documents...
This enables us to create, plan and execute drug development programmes effectively for our global customers, ranging from virtual start-up companies to established pharma companies. Venn’s capabilities and expertise includes CMC, Non-Clinical, Clinical Pharmacology and Development, Statistics, Study Design and Methodology, Data Management, RTSM...
In drug development, a proper clinical development strategy, implemented at an early stage of product development, helps to guide the success (and cost-effectiveness) of the product development. To understand the kinetics of a drug in terms of absorption, distribution, metabolism and elimination (ADME), pharmacokinetic...
Non-clinical testing is conducted throughout all phases of drug development to assess the safety profile and pharmacokinetic/toxicokinetic (PK/TK) characteristics of drug candidates. If performed well, it can identify key ‘knock-out’ criteria, maximizing the chances of success in subsequent stages of development. Strategies for the...
In order to ensure a good development trajectory for your potential drug compound a good understanding of the drug development process is indispensable. Each step in the process is linked to others and a large variety of expertise is typically involved for tackling all...
The project management of early development (phase 1/2a) trials requires a well thought and specific approach. Phase 1 trials form the basis of your further development, a well-executed phase 1 trial is therefore key to the further success of your compound. As an independent...
