Quanticate's Approach

Our approach to Clinical Data Solutions

At Quanticate we do more than just deliver clinical data services. We offer several different approaches that are flexible, add value, and support our clients. Quanticate is focused towards the customer experience we deliver and have many Case Studies and Testimonials from previous projects and customers.

Centralized Data Solutions

Having supported large scale Functional Service Provisions (FSPs) within data-related services over many years, such as biostatistics and clinical programming, Quanticate has been implementing an approach that provides the benefits of FSP through niche vendor expertise and flexibility, coupled with the advantages of cross-functional support and cross-study centralization. The creation of our Centralized Data Services (CDS) approach to clinical data outsourcing enables activities across functions to be supported in the most efficient way, utilizing experts, global capabilities, and a centralized data storage/visualization technology (iQ) to enable optimal use of clinical and safety data.

Since the core expertise of a full service CRO is clinical monitoring, site selection, feasibility, and site level interactions (a CDSP focused around the site, investigators, and patients), Quanticate can offer a data-focused CDSP solution to enable benefits of combining clinical data management, biostatistics, clinical programming, and elements of medical writing and pharmacovigilance. Our solution involves a combination of on-site and near-site experts coupled with off-shore and near-shore locations to optimize costs. We look at the total cost of the partnership, rather than just the outsourced FTE costs, to provide a solution that is cost effective, flexible, and easy to work within.

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Business Process Outsourcing (BPO) and Task Level Approach

With experience supporting a wide range of activities across various Pharmaceutical companies, Quanticate is able to support specific processes or tasks. To be efficient, Quanticate can provide solutions that utilize appropriate technologies using a global approach that best meet the needs and internal team requirements of our customers. Process or task activities may include:

  • Oversight of off-shore teams
  • Off-shore tasks - i.e. data entry, case management
  • Specific documents - protocol input, TFLs, publications, etc.
  • Region-specific documentation - i.e. PSURs, PADARs, etc.
  • Phase-specific support
  • Therapeutic-specific support
  • Tasks requiring experts interacting with clinical teams

We can work directly with sponsor companies or in collaboration with other CROs or Business Process Outsourcing (BPO) companies.

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A New Approach to Full Service Support

Quanticate can support clients in the traditional study service model. Quanticate have processes in place to ensure strong communication and a proactive approach to improvement across the team involved at the study, program, and sponsor level. 

Quanticate has extensive experience working with other CROs, vendors, and study teams to support clinical, safety, and marketing programs. These partnerships allow Quanticate to provide a full service CRO approach. This includes employees with experience across many therapeutic areas, and across Phase I, Phase II-III, and Phase IV/Post-marketing studies. Our iQ portal can be used to review data and documentation, create study level metrics, and communicate effectively between the study teams. If data from multiple studies and/or within a program are available, our visualization technology can help make access to this data easier.

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"Thank you very much for the document with the sample size calculations and especially for your additional thoughts on design aspects. This is very helpful and very much appreciated!"