Cambridge-headquartered regulatory affairs consultancy ELC Group has launched a clinical trials service.
Group CEO Marco Rubinstein said the new portfolio has been developed to help pharma clients speed up their regulatory submissions process.
“With our new clinical trials portfolio, we are delivering a full-service solution to help ease the regulatory approval process and shorten key timelines for our customers,” he said.
“Our clinical trials services are fully customisable, and can be offered on a standalone basis or as part of our integrated full-service package, offering ultimate flexibility to our pharmaceutical customers looking to expedite product delivery and create a competitive advantage in the market.”
The announcement follows a number of recent developments in the contract research organisation (CRO) market, which were highlighted in a report by Frost & Sullivan.
The trend for pharma and biotech companies to outsource research is set to continue, growing from approximately $6.07bn in 2011 to an estimated $11.54bn by 2018.
ELC Group is hoping to tap into this growing market by offers clients bioavailability/bioequivalence (BA/BE), phase I and phase II to phase IV, plus post-marketing surveillance, medical writing, biostatistics and statistical programming services, clinical data management (CDM) and training.
- Phase I services will include fully regulatory consulting support, protocol design, assistance with ethics committee submissions, as well as access to a clinical pharmacology unit and bio-analytical testing – delivered from a centre that is approved by all major regulatory agencies. During this stage, the group is also offering clinical study management, method development and validation, data management, pharmacokinetic analysis, statistical analysis and report writing
- During the phase II to phase IV, the portfolio includes study feasibility, site and investigator selection, site monitoring, project management, clinical trial supply management, as well as vendor management
- Clients will also be offered biostatistics and statistical programming services – covering all major therapeutic areas – and delivering insights into trial design as well as developing complex statistical analysis plans
- Other services include clinical data management for early clinical development and late phase clinical development programmes, including managing data for pharmacovigilance and pharmacokinetic/pharmacodynamic (PK/PD) services.
Finally, the offering is rounded off with the group’s Good Clinical Practice (GCP) auditing, quality assessment and risk analysis services, plus GCP training and workshops for IEC/IRB.