Parsabiv™ (etelcalcetide) is an intravenous injectable calcimimetic agent developed by Amgen for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) that were previously treated with haemodialysis.
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.
Steglatro™ (ertugliflozin) is a combination drug indicated for the improvement of glycaemic control in adult patients with Type 2 diabetes mellitus.
Lutathera (lutetium Lu 177 dotatate) for the Treatment of Gastroenteropancreatic Neuroendocrine Tumours
Lutathera® (lutetium Lu 177 dotatate) is a peptide receptor radionuclide therapy (PRRT) indicated for the treatment of somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours.
Kevzara® (sarilumab) is a human monoclonal antibody indicated for the treatment of adult patients with moderate-to-severely active rheumatoid arthritis (RA).
Qtern (dapagliflozin and saxagliptin) is a combination drug with sodium/glucose cotransporter (SGLT) 2 and dipeptidyl peptidase 4 (DPP-4) inhibitors indicated for the treatment of type 2 diabetes.
Spinraza™ (nusinersen) is an anti-sense oligonucleotide indicated for treatment of spinal muscular atrophy (SMA) in paediatric and adult patients.
Venclexta (Venetoclax) is an oral formulation developed by AbbVie in collaboration with Genentech and Roche, for the treatment of chronic lymphocytic leukaemia patients with 17p deletion.
Kovaltry (Anti haemophilic Factor VII (Recombinant)) is developed by Bayer as the treatment for children and adult patients with haemophilia A.