Quanticate Collecting, Analyzing and Reporting Clinical and Safety Data for Clinical and Post-Market Studies
Quanticate is a specialist clinical research organization (CRO) primarily focused on the management, analysis and reporting of data from clinical trials and post-marketing surveillance. We provide very efficient outsourcing solutions for companies who need additional capacity or who want to outsource certain functions in their entirety.
We deliver scalable on-site and off-site data management, statistical consultancy, statistical programming and analysis, medical writing and pharmacovigilance services. We also have a staff recruitment arm, ‘Quanticate People’, to help sponsors find all types of permanent and contract staff.
Clinical data management
Our data management team performs database build, data collection, data entry, query management, and coding of adverse event, medication and medical history data. We have extensive experience in helping our customers become CDISC compliant, and have undertaken numerous projects involving the migration of legacy data to CDISC standards. Quanticate uses whatever systems its customers prefer for EDC, clinical data management and ePRO and therefore has experience in many technologies.
Statistical consultancy services for clinical trials
We provide protocol development activities with input into the design considerations, statistical methodology to be used, as well as the sample size estimation. We will simulate the likely outcomes of the study under different scenarios.
Over the years many Adaptive Design and Bayesian methodologies have become widely used, but choosing the right ones at the right time is crucial to placing control over research programs at all stages of development. Quanticate consultants can help dispel some ‘myths’ and advise on the advantages and disadvantages of the different designs that you may be considering. Well-planned study designs ensure the best project go/no go decisions and lead to the earliest possible technical and regulatory success.
Services include producing a reporting and analysis plan, generating tables, listings and figures, performing statistical analysis, and providing DSMB support.
Statistical programming for clinical studies
Whether we are using our internal global macro library, a client’s internal environment, or developing customized software solutions, Quanticate programmers are industry leaders in providing validated results to clinical study reports and submission-ready deliverables. Quanticate has over 100 full-time programmers.
Medical writing consultancy
Quanticate’s medical writing services include clinical and regulatory writing as well as scientific communications, education material and medical writing consultancy. Our medical writers have a wide depth of knowledge and experience drawn from the pharmaceutical industry, contract research organizations and academic research. All documents produced by Quanticate undergo thorough scientific, statistical, editorial and quality control review.
Quanticate offers a range of pharmacovigilance services throughout all phases of clinical development and post-marketing. There is advantage in centralizing all safety data, clinical data, analysis and reporting with one provider. By combining Quanticate’s substantial biometrics, medical writing and pharmacovigilance expertise, we offer a fully compliant and high-quality complete package of pharmacovigilance services.
Our goal is to help our customers meet strict regulatory requirements, along with managing the risk-benefit profile of products, in order to maximize product potential, whilst ensuring patient safety. From outsourcing of individual activities, to the set-up and management of an effective and efficient global pharmacovigilance system, Quanticate provides solutions specific to the requirements of our customer’s organization and products.
Project management services for clinical trials
A key element of successful project delivery is effective project management. Quanticate project managers offer each customer an accessible, single point of contact for project communication, timely delivery of milestones and budgetary control. Our project managers have extensive experience in managing projects on behalf of our customers, organizing and coordinating the efforts of both the customer and other CRO resources to ensure projects are delivered successfully.
Strategic resourcing for clinical trials
Quanticate is well known for its ability to provide dedicated teams of people such as SAS programmers, statisticians, data managers and medical writers. These teams are dedicated to a customer for a specified period of time. Sometimes referred to as Functional Service Provision (FSP), this solution gives sponsors an extension of their clinical team for as long as needed.
It usually involves Quanticate employees working from our own offices but connected to the sponsor’s IT infrastructure. We can also provide people to work on site. In addition to Quanticate employees, our solution can be augmented to include contractors or permanent staff placements provided through our recruitment business, Quanticate People.
Products and Services
Parsabiv™ (etelcalcetide) for the Treatment of Secondary Hyperparathyroidism (SHPT)
Steglatro (ertugliflozin) for the Treatment of Type 2 Diabetes
Lutathera (lutetium Lu 177 dotatate) for the Treatment of Gastroenteropancreatic Neuroendocrine Tumours
Kevzara (sarilumab) for the Treatment of Rheumatoid Arthritis
Qtern (dapagliflozin and saxagliptin) for the Treatment of Type 2 Diabetes
Spinraza (nusinersen) for the Treatment of Spinal Muscular Atrophy (SMA)
Venclexta (Venetoclax) for the Treatment of Chronic Lymphocytic Leukaemia
Kovaltry (Anti-haemophilic Factor VII (Recombinant)) for the Treatment of Haemophilia A
A new paper released by Quanticate provides an overview of some of the ways in which Phase I packages can be tailored to the needs of the specific compound and conducted more efficiently using combination, flexible protocols. It outlines the considerations that need to be made at the planning staRead more
Quanticate has released a free-to-download white paper entitled 'Bayesian Study Design: The Pragmatic Solution for Phase II Clinical Development'. Statistically powered studies in phase II clinical development can be large and expensive, and may not be appropriate at a stage in developmRead more
Quanticate, a global biometrics clinical research organization (CRO), today announced the rebranding of its staff recruitment solutions division from 'OPS Search & Selection' to 'Quanticate People'. With this branding initiative, Quanticate launched its new Quanticate People website, www.QuanRead more
Quanticate is offering free training in various SAS® procedures and techniques. If you are a SAS user wishing to extend your knowledge of SAS software and build efficiency into your coding, we are running free training sessions to help you improve your skills. You should have at least threeRead more
Quanticate's second whitepaper shows how the Bayesian framework is highly appropriate for planning and executing interim analyses: The rationale for using a Bayesian approach to interim analyses is explained The formulation of interim decision rules on the basis of postRead more
Quanticate would like to invite you to our February networking event to learn more on early decision making in clinical development. Our expert speaker panel will look at the concept of smarter study designs that compress timelines and costs in early clinical development. If you are already plannRead more
During an interview with eCliniqua magazine, Alison Bond, Quanticate's new head of pharmacovigilance, said: "The key to pharmacovigilance is the collection of high-quality, accurate data. It's about collating reports of adverse events during clinical trials and post-marketing, as well as lRead more
Quanticate, a global biometrics clinical research organisation (CRO), today announced that it has appointed Dr Alison Bond to lead its new pharmacovigilance services team. The appointment further supports Quanticate's mission in continuing to expand its clinical trial services offerings to supporRead more
Quanticate, a global biometrics clinical research organization (CRO), today announced that it has received the 2010 Kinetic Process Innovation Award for excellence in clinical data management and clinical trial services. Quanticate's statistical programming and analysis and superior medical writRead more
Hertfordshire SG5 1LH
101 Main Street, Suite 1720
United States of America