Mehdi Chelbi, Business Development Director
Back in 2005, most pharmaceutical organizations employed a handful of resources to manage their clinical trials. However, with increasing technology adoption and ever-growing amounts of clinical data, such organizations now require more persons to collect, analyze and report data. The founders of 4Clinics have closely observed the transformation from an ‘all handled internally’ approach to extensive outsourcing of these activities. By leveraging their expertise in data management, statistics, and medical writing, they laid the cornerstone of 4Clinics—a Contract Research Organization (CRO). 4Clinics provides biotechnology companies, medical device companies, and pharmaceutical organizations with experts who can obtain, analyze, and publish clinical data effectively. “Data management, statistics, and medical writing solutions are in our DNA,” says Mehdi Chelbi, Business Development Director at 4Clinics, “4Clinics brings these services together and includes them with study management and clinical operations under one umbrella, thus allowing enterprises to customize a platform of experts on the basis of their specific business requirements.”
4Clinics’ services are separated into three business models. The first model adopts the classical approach of outsourcing clinical activities, where 4Clinics delivers services to accommodate a specific and well-defined need. The company optimizes the delivery of key activities, data, and documents while controlling cost and ensuring quality. The second model offers remote platforms that are comprised of data management, biostatistics, statistical programming and medical writing capabilities, either as stand-alone or in a bespoke combination. In the third model, 4Clinics’ services act as an extension to the workforce of their clients. This three-model strategy caters to a wide range of research organizations, as it allows 4Clinics to provide services in harmony with other specialized vendors. This flexibility has permitted 4Clinics to position itself as a leader in the medical writing, statistics, and data management domains.
By leveraging data aggregation and analytics capabilities, 4Clinics provides clients an expert platform that collects, analyzes, and publishes clinical data effectively
Many of 4Clinics’ implementations have translated into success stories for their clients. In one such instance, a company in its infancy with a pipeline of several vaccines and immunotherapeutic candidates requested that 4Clinics develop a customized solution for the management of clinical data and reports. 4Clinics provided a cross-functional biometry and writing platform to manage clinical data, program statistical outputs, generate statistical analyses, check data standards compliance, and to develop clinical and regulatory documentation. This unique and flexible solution helped this client to gain time (through the use of a single point of contact, regular and ad hoc reporting, a pool of trained experts, and streamlined processes from CRF design to study reporting) and to reduce costs by optimizing synergies across studies (building of a data repository, development of SAS macros, and development of document templates).
4Clinics’ team is composed of medical, clinical, scientific and operational specialists. The highly trained and experienced professionals at 4Clinics have extensive experience with international clients.
Moving ahead at full steam, 4Clinics has recently expanded into the US market, with a new operational center situated in Cambridge, MA.
4Clinics aims to promote its new solutions portfolio: access to databases for patient recruitment and stratification in immuno-oncology, pre-qualified investigation centers specialized in vaccines, analytical tools to identify and rank potential investigation centers for rare diseases, and design of Patient Reported Outcome smartphone applications to generate Quality Of Life data. 4Clinics is also setting up a scientific board to guide study design and protocol development for companies moving from the pre-clinical to the clinical phase.
4Clinics forecasts the expansion of its partner and client base in vaccines and immunotherapeutics (especially in immuno-oncology), alongside its client portfolio in medical devices and regenerative medicine (including cell and gene therapies).