Xcene Research has extensive relationships with leading medical centers as well as experienced investigators across Sub-Saharan Africa. This gives us unparalleled access to patients, patient data, and expertise and perspective of physicians who are leaders in their field. Our clinical research professionals identify, translate, and answer complex questions while working with you to advance the practice and the future of medicine.
All studies conducted by Xcene Research are in-line with FDA and ICH- GCP standards.
The Key services of Xcene Research are:
Achieving a quality clinical trial begins with an effective, well-managed start-up phase. At Xcene Research, our team of global professionals are capable of handling all aspects of start-up in Sub-Saharan Africa, especially for those companies located in Sub-Saharan Africa. Xcene Research has a dedicated team to help get studies under-way. We have experience in working with a range of investigators and have contacts in establishments ranging from respected academic institutions to private research clinics.
Xcene Research site Intelligence & activation specialist performs due diligence with all sites and personnel before study start up. Our unique blend of expertise and contacts ensure that Xcene Research understands the unique and often complex needs of testing sites and personnel. And so that there is no time lost, we offer reviews before start-up so that changes can be pro-actively implemented. Our specialist ensures quality control throughout the documentation process, while maintaining flexibility to work within client parameters.
Xcene Research offers Investigator training, CRC/CRA training and GCP training through Xcene Research Academy. Our training consultants have many years of experience within the clinical research and pharmaceutical industry.
Our team offers clinical trial monitoring at all levels, from early Phase I through large Phase IV programs. We work with clients to design programs from a menu of research options. From site qualification to close out, Xcene Research CRAs monitor patient eligibility, protocol implementation, data collection, adverse event reporting, regulatory document maintenance and a battery of clinical study performance metrics to ensure each study’s integrity.
Xcene Research provides a range of data management solutions, ensuring data life-cycle control, quality and security. XCENE Research Data Management team collaborates with our clients to tailor project approaches that best meet each client’s needs and to ensure timely and reliable data analysis. We leverage quality processes and project specific data management documentation to produce accurate and robust clinical databases for analysis and reporting. Our data managers are proficient in the use of technologies including Rave®, InForm™, Oracle® RDC, Oracle, Clinical™, Clintrial, ePro solution, optical scanning and work flow systems. Our experience and understanding of Electronic Data Capture (EDC) processes and systems enables us to provide the optimum solution for each project. We offer a full range of EDC services that can be combined to meet virtually any need. Our expert certified resources work with customers internally and externally to ensure each trial is developed to the highest standards using the latest technologies in the marketplace for clinical trials.
Project management is both art and science. Xcene Research specializes in setting clear, achievable research goals and following those goals to completion through clear communication, strong organization and effective reporting. XCENE Research works in partnership with our clients throughout the project to jointly achieve the goals of the clinical investigation. The assigned data management project manager uses several methods of communication to facilitate this partnership including documentation (e.g., data management plan, contact matrix, timeline, project specific processes and procedures); correspondence by memo and e-mail; teleconferences and face-to-face meetings; and standard and customized status reports delivered per an agreed-upon schedule.
The Internal Review Board (IRB) submission process is one of the most complicated aspects of gaining approval for new clinical studies. Our experienced team happily manages this process on behalf of our clients.
Through effective marketing and rigorous screening, Xcene Research ensures the best possible patient recruitment phase for our clients seeking clinical trials. A dedicated, seasoned patient recruitment and retention specialist is assigned to each clinical program for focused execution and oversight. Xcene Research patient recruitment and retention services uses innovative techniques to accelerate patient enrolment. We ensure each process is streamlined to optimized performance at every stage of the trial while simultaneously minimizing risk and maximizing efficiencies.
Xcene Research Regulatory Affairs team provides seamless and transparent global regulatory services to clients across the full range of the clinical project life cycle for pharmaceuticals and medical devices. Our approach is based on an in-depth understanding of each client’s project; a strategic analysis of the appropriate regulatory needs; advanced planning to meet timelines; and strong execution of regulatory filings, agency communications and compliance with regulations. Through all trial stages, Xcene Research works closely with both clients and regulators in the regulatory development phase of the trial process, promoting clear, two-way communication and positive outcomes.
Our network of central laboratories offer a breadth of solutions during the trial phase, such as standard and customized testing, and well-documented, valuable data.
Xcene Research sources the best clinical supplies at a low cost through our network of third-party vendors. We manage the full supply chain, and handle distribution and delivery to trial sites.
Our quality and compliance officers help make Xcene Research a leading Sub-Saharan Africa clinical trial company. Through site and data audits, document review, system audits and vendor oversight, we ensure that our sponsors’ clinical trials meet the highest standards of review.
Our medical and safety management team protects patients throughout the clinical trial process. We provide pre-trial safety assessments, structured adverse event planning and standardized safety protocol and reporting systems.
Xcene research provides the latest electrocardiogram (ECG) equipment and analysis in support of your Phase I-IV clinical trials. Our team of ECG professionals are knowledgeable and highly trained.
Let our team work with you on clinical trial management. Our global professionals have the expertise to solve even the hardest problems related to Phase I-IV clinical trials.
Partnering with Xcene Research tells everyone that you are committed to quality and safety in the clinical trial process. Find out how a partnership with our team can help take your trial to the next level.