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15-Apr-2021

T-TOP, The Taiwan-based CRO Provides Entire Clinical Study Data of Efgartigimod Alfa For EMA Authorization

T-TOP, The Taiwan-based CRO Provides Entire Clinical Study Data of Efgartigimod Alfa For EMA Authorization

One-stop Solutions Provider For New Product Development In Pharma And Biotech Industries

 

TAIPEI, TAIWAN - T-TOP Clinical Research Co., Ltd. is a Taiwan-based contract research organization (CRO) that offers clinical study support for drugs and medical devices. The company will be showcasing its professional services at BIO Asia-Taiwan 2021 in Taipei Nangang exhibition center between Jul 23 - Jul 26. In 2020, its entire clinical study data of Efgartigimod alfa met the requirement of European Medicines Agency (EMA) authorization and received positive feedback from the Paediatric Committee (PDCO) of EMA.

 

T-Top offers cost effective CRO services with therapeutic expertise along with technological and management resources to pharma, biotech, and medical device manufacturers. By partnering with a CRO, companies can significantly reduce the costs of clinical research and new product development time. Its complete range of services includes protocol development, ICF development, CRF development, regulations submission, site monitoring and management, start-up activities, clinical trial project management, data processing and analysis, and clinical trial reports and audits. With the coronavirus pandemic, T-TOP expects significant growth in demand and continuously extends its service areas to provide high-quality, diverse, and efficient services to meet the market demands.

 

Competitive Advantages:

• Electronic system for IND and NDA submission (eCTD, PV, eTMF, and EDC, etc.)

• Professional medical writing, statistics & data management, and clinical operation

• Follows strict ICH GCP guidelines

 

About T-TOP Clinical Research Co., Ltd.

Founded in 2015 and headquartered in Taipei, T-TOP is a contract research organization (CRO) specializing in clinical research and project management. It is poised to accelerate the process and reduce the costs for new product development. T-TOP's extensive experience covers various therapeutic areas: antibacterial, cancers, diabetes, Alzheimer's disease, vaccines, and more. The company values the importance of ethics and integrity, and is looking to partner with more biopharmaceutical companies worldwide. For more information, please visit https://ttopcro.com/.

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Last Updated: 15-Apr-2021