Gaining regulatory approval does not always depend on including clinical site data within your regulatory submission.
Regulatory agencies have increasingly acknowledged the value of real world evidence (RWE) in providing insights into the safety and effectiveness of drugs outside of controlled clinical trial settings.
Advances in technology, such as electronic medical records (EMR), wearables, and sensors, have facilitated the collection of real world data (RWD). This increased availability of data from diverse sources, including registries and healthcare databases, has expanded the opportunities for leveraging real world evidence in clinical trials and real world studies.
At Quanticate our team of experts has 115 years combined of experience in Real World Data, acquired while working across multiple Therapeutic Areas (Oncology, Rare Diseases, Vaccines, Inflammation & Immunology, Internal Medicine, Infectious Diseases). Our team can provide your organisation with their expertise on topics such as new drug/device safety and efficacy, health economic outcomes research (HEOR) and observational studies.
Improve the Quality of Your Submission with RWE
Harnessing RWE unveils powerful insights into daily medical practices and the complexities that accompany them. Such profound understanding becomes a pivotal tool for fostering informed choices, boosting safety, enhancing treatment efficacy, and, most importantly, elevating the standard of patient care.
Embracing RWE paves the way for a more intelligent and influential methodology in advancing healthcare.
When leveraging more data sources into your investigational drug analysis it makes sense to partner with a specialist Biometric CRO.
At Quanticate we are experts in Data and Biostatistics, our 3 decades of experience as a biometric CRO has built up strong processes for interrogating and analysing data from a wide range of sources, and utilising new market leading technologies. This allows us to provide fast, quality and efficient data deliveries. This experience gives us the perfect characteristics when choosing a CRO to partner with for your RWE strategy.
As you face the challenges of handling more data from diverse sources, and incorporating this real world data into your existing randomised clinical trial, having a specialist biometric CRO partner can help solve the challenges you will face.
With 115 combined years of experience in handling and processing RWD, across all biometric operations over a range of therapeutic areas your trial will be in safe hands. From working with top tier pharmaceutical companies to small biotech’s, we can provide RWE support on any project regardless of its size. We understand the challenges different drug developers can face and their requirements to gain a successful approval.
Our Database Experience
Our team are skilled in using the following:
Optum (Integrated, MarketClarity)
Humedica (Panther)
CPRD (Aurum, Gold)
Flatiron
Komodo
Omny
Truven Marketscan
Pharmetrics
![Real World Evidence in Drug Development [Podcast]](https://www.quanticate.com/hs-fs/hubfs/Real%20World%20Evidence%20Podcast-1.jpg?width=450&name=Real%20World%20Evidence%20Podcast-1.jpg)
