Clinical Resarch
Within the clinical research department, all efforts are invested according to the most up-to-date standardized procedures (SOP) to deliver services of feasibility of research project, protocols elaboration, submission to regulatory authorities, implementation, monitoring, validation and coordination of clinical biology services, pharmacovigilance monitoring , reporting and reconciliation of events , IMPs management , data verification and storage ; site closures and medical writing of end of study reports.
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Health Market Research
The healthcare industry is undergoing rapid change, dynamic discoveries and pressures driving business decisions and corporate growth. Business models are being forced to evolve as healthcare continues to shift from a treatment focus to points of wellness, prediction, personalization, and prevention. Our core program areas , Pharmaceuticals , health practices , connected health, Life Sciences and Advanced Medical Technologies—help you to better understand buyer-seller dynamics as the healthcare system transitions to digital information, the pace at which new and innovative medical devices and systems are being adopted and getting embedded into the typical clinical pathway ...
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Pharmacovigilance
The rapid induction in the market of new health products throws up the challenges of monitoring Adverse Drug Reactions (ADRs) over large population base. All health products , pharmaceuticals, medicla devices, cosmetics and vaccines have potential side effects. Some of these side effects are known, while many are still unknown even though that medicine has been in clinical use for several years. It is important to monitor both the known and hitherto unknown side effects of products in order to determine any new information available in relation to their safety profile ...
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Data Management
Our CDMS is adaptative to both methodology used , paper data collection or electronic data collection. Our data validation process is comprehensive and robust .Minimal requirements for data management should be regarded as the starting level to be able to participate in common trial activities . In this sense, minimal requirements identify the level of minimum quality standards that could be assured to external partners wishing to make use of the abilities of Poseidon CRO . This level is defined clearly and explicitly, so that system audits can be performed easily ...
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Biostatistics
Beyond usual services to industry , such as subject number determination , protocol conception, data analysis , models verification , our biostatistics and bioinformatics buisness unit provides statistical advice and support to researchers during the preparation and the implementation of project proposals. The objectives are to maintain the high quality of clinical research and improve the statistical skills of collaborators , in classical fields ( epidemiology , clinical research ) but also in exciting new challenges such as biosimilars and drug design ...
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Medical Writing
Pharmaceutical companies has come to outsource non-core activities in an effort to control costs and enhance drug-development cycle time. One of these activities is medical writing—an area that, although not at the core of pharmaceutical operations, has become increasingly critical as regulatory agencies have adopted more elaborate review measures that require substantial amounts of documentation. Through its team of highly qualified and knowledgeable professionals, our CRO is a trusted partner in all areas of medical writing ...
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Legal advisory for Life Sciences
With our core experts in health and safety codes through our area of coverage , for drugs , medical devices , cosmetics , nutraceuticals and all health biotechnology derived products, we help you gain time , and efforts in constituting a comprehensive framework for all the aspects of your operations : marketing , representation , retail , customs clearance , intellectual property , patent transfer and registration , clinical developpement , technology transfer , import and export of biological samples , etc ...
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IMPs Management and Cold Chain Services
For the cold chain services we use th most comprehensive temperature monitoring solution wich is achieved by using data loggers. These are devices that continuously record the temperature in the room they are placed in. The temperature is measured and recorded at pre-defined intervals , and the data report is editable on a simple connection with USB port . As per the GCPs recommendations we ensure written procedures including instructions that the investigator/ institution follow for the handling and storage of investigational product (for the trial and documentation thereof) ...
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