Angelique Arnauld 1591-1661
"Perfection consists not in doing extraordinary things, but in doing ordinary things extraordinarily well."
Our key services include:
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Regulatory Affairs
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Clinical trial management
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Project Management for local and international projects
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Clinical trial monitoring
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Study Start-up
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Patient recruitment and Retention
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Feasibility studies
Regulatory Affairs:
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Perfection-CRO provides effective local regulatory affairs services for all stages of pharmaceutical, biologic and medical device product development and lifecycle management.
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Local submissions to Helsinki, MOH for drugs, medical devices and biologics.
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Global clinical trial applications through our strategic alliance
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Preparation, submission and maintenance of IND,IDE, and CTAs
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Preparation and submission of documents to Competent Authorities
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Regulatory consultancy
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Preparation and submission of all applications
Study Start-up:
Study start-up and activation is one of the key milestones in your program. It is an important component of clinical trials and has a critical impact on subsequent trial timelines, as well as site relationships. Site identification and activation is an important component of clinical trials and has a critical impact on subsequent trial timelines, as well as site relationships.
Clinical Trials Management:
Our Clinical Operations staff are skilled in clinical trial management, clinical monitoring, expedited study start-up, patient recruitment and retention, and in the execution of study feasibility assessments. We pride ourselves in being able to skillfully execute the vital operational best practices needed to ensure that the trial is conducted according to plan, with high quality, within timelines and cost effectively.
Patient Recruitment and Retention:
We understand the challenges and importance of a successful patient recruitment program. We take a proactive approach to develop a strategic enrollment plan with the sites. We also ensure that patients are retained in the project and assist the sites to avoid drop-out patients.
Project Management:
Project Managers assigned to the project will map out operational objectives that are likely to have the most direct and most significant impact on the time, quality, cost, and outcome of your program. Our study managers will lead the dedicated project team and ensure that the trial remains well planned and executed throughout the project life cycle. The Project Manager will have the primary responsibility of communication with the client for CRO activities for the duration of the project. Our project managers are experienced in conducting clinical trials and know well their responsibilities which include project/client communication, team management and motivation, planning and controlling of project timelines, vendor management, ensuring high project quality, management of resources and budget, escalation of issues and initiation of measures for problem resolution
Feasibility Studies:
Through our network of contact we can collect and summarize valuable, detailed feedback from clinical research sites to support critical decision-making in the clinical development program. We can help determine important parameters such as patient enrollment rate, number of sites needed, local standard of care, viable patient assessments, potential study challenges, and investigator grants. We will collect the specific site feedback needed to make the study a success. The information our team gathers is summarized in a feasibility report with key recommendations.