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Clinical Development
Medical Writing
We provide the development service for clinical trial protocols, informed consent forms and clinical study reports in accordance with ICH-GCP/KGCP, and the regulations and guidelines from Ministry of Food and Drug Safety (MFDS, Korea), FDA and EMA.
From regulatory clinical trials of drug and medical device including digital therapeutics(DTx), to observational and post-marketing surveillance studies, Spero ensures systematic and ethical clinical trial planning documents.
Study design tailored to decentralized clinical trial process
A protocol governs all aspects of clinical trial activities in the field, and in decentralized clinical trials, a well-designed and clearly written protocol has critical role in communicating important new elements of the trial to investigators, IRBs, and regulatory authorities.
Development of clinical trial documentation requires specialized, cross-functional team collaboration.
Spero provides scientific and logical clinical trial protocols with various clinical trial elements designed in the right place through a professional development team and conducts QC based on domestic and international guidelines.
Protocol definition :
Develop a detailed protocol describing the clinical trial's objective, design, methodology, eligibility criteria and endpoints.
We ensure that it conforms to the principles of decentralized clinical trials and remote data collection methods are properly integrated.
Technology check :
Evaluate and select appropriate technology solutions to support the decentralized elements of the upcoming clinical trial.
This may include remote data collection devices such as clinical trial data capture systems, remote monitoring, telemedicine platforms, in vitro diagnostic and wearable devices.
Process
Service Scope
CSR
(Clinical Study Report)
RA Submission
Follow-up
Protocol, ICF and Trial-Related
Document Development
CTD
(Common Technical Document)
Service Scope
CTD
(Common Technical Document)
CSR
(Clinical Study Report)
RA Submission
Follow-up
Protocol, ICF and Trial-Related
Document Development
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