Clinical Operations include various activities which support clinical trial process from inception to submission. Our scientific and therapeutic knowledge, operational expertise and regulatory support will help you to meet your needs in this ever evolving clinical research world by providing comprehensive clinical trial services. Abiogenesis Clinpharm clinical operations team have hands on experience in multiple therapeutic areas including but not limited to rheumatology, psychiatry, oncology, cardiology, infectious disease, nephrology, neurology, ophthalmology, endocrinology and pain management.
Our team has capability to manage wide range of patient population (phase 1 study to cluster based large community studies). Our clinical research services have been compiled using inclusive, globally compliant processes to ensure that all regulatory requirements are fulfilled or upheld during the entire life cycle of the clinical study. Tasks are constantly and closely observed, with results evaluated in accordance with quality standards, contractual deadlines, and stringent financial constraints.
At Abiogenesis Clinpharm, we are proficient in conducting decentralized trials and real-world studies. Our clinical operations team is swift and adaptive to meet the complexity of clinical trials and the stringent regulations by providing end-to-end support for the smooth conduct of clinical trials. We offer comprehensive services to meet the sponsor requirements by focusing on the deliverables with a customizable approach throughout the life cycle of the clinical study.
Clinical Operation Services
Clinical Project Management
Clinical Project Management is very necessary for successful completion of clinical trials. We foster an environment of clear communication and collaboration with stakeholders for better decision making and streamlining the entire process. At the heart of clinical trial project management, there’s a team that’s both highly skilled and fully integrated, each member committed to the success of your project and providing the advantage of a single, accessible contact for smooth communication and coordination throughout every phase.
Stakeholders Management
One of the key tasks throughout the clinical study process is managing internal and external stakeholders through clinical operations management. In order to improve decision-making and aid in the accomplishment of the clinical study goals, the primary goal of stakeholder management is to keep all parties involved and informed about every matter pertaining to the clinical study activities. We strive to maintain open and simple communication process to ensure smooth and unambiguous communication flow which empowers the team spirit in meeting the objectives.
Risk Identification and Mitigation
Our proficient clinical operations team takes the initiative right from the beginning of the clinical study to identify risks, assess their impact and develop a comprehensive risk management strategy. Our approach is to implement mitigation strategies for trial success
Site Management
Our clinical operations team understands the clinical study requirements by performing site identification, feasibility, selection, initiation, recruitment, monitoring and management of sites. Primary focus during this process is to meet regulatory requirements, patients safety, clinical sites and quality data for the smooth conduct of clinical studies. At Abiogenesis Clinpharm, we have a well established processes in place to perform both remote and onsite management activities.
Quality oversight
We at Abiogenesis, are aware that maintaining the integrity and success of clinical studies depends critically on quality oversight in clinical operations. In order to meet operational excellence standards, our highly skilled quality assurance team works in tandem with the operational team to ensure that processes adhere to rules and regulations. Our quality assurance procedures are designed to be manageable and not unduly complex. The quality oversight, which includes constant observation, conformity to guidelines, and efficient communication to uphold the greatest standards in clinical operations, supports our operational efforts.
At Abiogenesis, we are dedicated to utilize our expertise and advanced technologies to excel in clinical trial operations. Our team is more inclined towards attention to detail which helps our sponsors to expedite regulatory approval process and brings the innovative therapies into the market at a faster pace.