Biosimilars and Biologicals clinical trials

Biosimilars And Biologicals Clinical Trials

Biosimilar/Innovative Biologic trials require a customized approach based on the therapeutic indication and study specific goals. We work with our clients to develop an effective plan and execution strategy for Biosimilar and Biologics clinical trials that includes subject recruitment, regulatory, clinical safety monitoring, specialized pharmacy expertise, and bioanalytical support while ensuring subject safety throughout the entire trial

Why Partnership with Triumpharma for your Biosimilar and Biologics Clinical trials?

Distinctive Recruitment Strategies

Through our proprietary large database for healthy volunteers called Clinical and Medical Information system “CMIS”, large database of patients, referrals from our large network of physicians, and up-to-date feasibility data. Thus, our clinical research units ensure a fast recruitment of healthy volunteers and patients into Phase I biosimilar/biologics trials.

Dedicated Research Team

At Triumpharma, our staff includes a dedicated Project management team, Clinical experts, Data management, Regulatory professionals, Physicians, Investigators, logistical, Medical Writers, Bio analytics, Quality Assurance and Training service, with extensive experience in conduction of Biosimilars/Biologics clinical trials for local and global registrations.

Understanding Regulatory requirements

We are flexible in adapting the various guidelines of JFDA, EMA, US-FDA and many other regulatory agencies all over the world. An example being our in-depth understanding of the PK, PD and immunogenicity requirements for biosimilar/biologics trials.

Specialized Pharmacy

Our facilities are ideally designed to support biosimilar/biologic clinical trials as our pharmacy room is well equipped and meets the Regulatory Requirements.

Biosimilars/Biologics Experience/Capabilities

We have taken part in several successful conduction of biosimilars, Biotech drug and Orphan disease clinical trials from Phase I-III with successful marketing authorizations in Europe, and other regions, registration trials on both healthy subjects and patients, including the following:

Class	Molecule	Clinical therapeutic trials	PK
Hormones	Darbepoetin		√
Monoclonal Antibody	Ianalumab and Lanadelumab	√
Fusion protein	Etanercept		√

Clinical trials from Phase I-III of Monoclonal antibodies/protein derived molecules, such as: Warm Autoimmune Hemolytic Anemia (WAIHA), Hereditary Angioedema (HAE) and Rheumatoid Arthritis.