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Clinical Trial Management

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Managing clinical trials of any size and complexity, requires thorough planning and an efficient team to execute. For large global trials or focused regional studies in all study phases, our talented trial management team makes all the difference in how well your trials are run. Based on your specific requirements we can deliver a variety of clinical development services customized to fit your objectives, whether you need a single function across several drug programs, a range of functions within a single therapeutic area, a complete staff lift-out or any other defined need. We will be the right partner that you are looking for!

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Study Start up Services

Cedent provides assistance in moving clinical trials through the start-up process : Our SSU groups/Consultants are equipped with latest strategies to help facilitate the startup process, drive industry-leading cycle times and offer additional flexibility in response to our client’s outsourcing demands. Our study startup services include:

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Site Management & contract Services

Cedent develops strategic partnerships and establishes relationships with Sponsors/CROs and Investigative sites. Cedent facilitates quick start-up and support to principal investigators to ensure that studies are completed in a timely manner while adhering to all the regulations and laws governing clinical research.

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Project Management Services

Cedent considers project managers (CTM/PMs) to be among our most important assets. Through a sound team structure, close communication, detailed tracking and measurement, our Project Management group delivers consistently high quality for our clients.

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Regulatory Services

In the regulatory services group our partnership with clients spans all phases of drug development. We routinely provide strategic advice and consulting for IND submissions all the way to NDA submissions and post-marketing trials. Cedent’s clinical trial management scope, experience and efficiency in regulatory consulting are strengthened through its integration with our expert clinical, medical writing and statistical teams.

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Data Management Services

Without clean, reliable data, no trial can be successful. Our study-specific approach to data management begins with a careful review of the study specifications, client preferences, history, data to be collected and technologies available. We then provide guidance to our clients on the most appropriate method for data collection to best serve the needs of study sites and project team.

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Statistical & Data Analysis Services

Cedent biostatisticians are highly experienced in all aspects of clinical trials, from the initial stage of planning the design and calculating sample size requirements, to analyzing, displaying and interpreting data in the final stages of the study. In addition, our biostatistics team has significant experience preparing analyses for regulatory submissions in a manner that facilitates their review.

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Medical Writing Services

Cedent Medical writers perform critical work that will allow our clients to take healthcare further, together. Our highly skilled consultants, will impact your strategies to develop regulatory pathways for your diverse product portfolio around the world.

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