CLINICAL RESEARCH OPERATION AND SITE MANAGEMENT

Clinical Trial Management

Locate New Studies

We provide support in identifying clinical research studies tailored to your facility’s requirements.We specialize in phase 1-4 pharmaceutical, device, and diagnostic clinical trials in a variety of therapeutic areas.

Project /Data Safety Management

Effective management involves the art of assembling the right individuals with the right concepts, synchronizing their efforts at the opportune moment, and converting ideas into tangible results. Our team of seasoned managers, in collaboration with their skilled associates, excels in implementing top-tier management methodologies to ensure superior outcomes that are both efficient and cost-effective. Whether it’s project management, data management, or safety management, our committed team is well-equipped to manage and execute every task within the designated timeline, aiding you in reaching every project milestone successfully.

Operational Management Team

It can take many years for a molecule to travel from laboratory concept to marketed product. It is important that your molecule is given the utmost attention and support at every phase of its clinical trial journey. Whatever the therapeutic area or complexities of the new medicine, the goals are simple: establishing the fit for purpose balance in the safety and efficacy profile and so achieving approval in the minimum time and at the lowest cost. Whilst this is easier said than done, contact us to learn more or to get a quote.

Audit / Inspection Readiness

A well-executed inspection or audit, underpinned by a sustainable, integrated framework, can significantly mitigate the severity of findings or, in some cases, prevent them altogether. Central to establishing a state of readiness is the demonstration of consistent operational performance, along with the compliant, well-organized management of all outputs. At Proficient Clinical Research, we’ve identified three critical components for an Audit and Inspection Readiness capability: Inspection Management, Inspection Preparation, and Inspection Infrastructure. Every team hosting an audit or inspection aspires to be fully prepared whenever the event occurs. Through the right processes, tools, roles, and meticulous preparation, Our team will swiftly and efficiently come together, providing regulators with information that unequivocally demonstrates an appropriate level of control over the drug development process. This allows teams to focus on the science rather than being burdened by last-minute emergencies and the scramble to find answers.

Regulatory

We ensure compliance with all relevant regulations and guidelines in the conduct of clinical trials at your site.

Monitoring

We don’t simply conduct monitoring; at Proficient Clinical Research, we emphasize cost-effective monitoring that aligns with the specific needs of your project. Our monitoring services encompass routine monitoring, risk-based monitoring, remote monitoring, and customized project monitoring. We equip our monitors with essential tools and training to optimize their on-site visits and prioritize tasks efficiently. The Proficient Clinical Research project team closely evaluates the results of each activity and conducts trend analysis to swiftly address and resolve issues.