Clinical Development Services

Clinical Development Services

Our Clinical Trials Capabilities:

We help our clients introduce new and innovative pharmaceutical products to the market in a timely and cost-effective manner.
Our skilled staff collaborates closely with sponsors to provide the optimum solution for each project and to execute high-quality clinical studies.
Our highly experienced, locally based staff enable us to provide flexible and innovative options for reaching patient groups, ensuring that our clinical trials have a positive impact on sponsors, physicians, and patients.

clinical trial

Clinical Trial Services

  • Conducting site feasibility & site set-up activity
  • Site contracting and budget negotiation
  • Essential documents collection and processing
  • Site initiation, interim monitoring, and study closure visits
  • Regulatory services – application processing, technical presentation, liaising
  • Site monitoring, project management & safety monitoring
  • Overall site management and communication
  • Site training and audit support
  • Pharmacy – IP management / central storage and distribution.
  • Laboratory services, including PK and immunogenicity analysis capabilities
  • Data management, biostatistics, including eCRF capabilities
  • Safety database and pharmacovigilance
  • Medical writing – Protocol, ICF, IB, and study report, etc.

Early Phase Clinical Development

Early Phase Clinical trials are an important and necessary aspect of the drug research/clinical development programme for understanding the nature, PK/PD, safety, and POC of a novel medicine. Further clinical studies might be planned based on the data gained on safety and efficacy. A phase I clinical study allows for an early assessment of the product’s safety and tolerability characteristics. It can also provide information on C-max, T- max, AUC, and T1/2, allowing subsequent research to be planned accordingly.
It can also give pharmacodynamic data, which can suggest the drug’s safety and effectiveness, even in healthy patients. Single Ascending Dose (SAD) studies, Multiple Ascending Dose (MAD) studies, gender studies, Food impact studies, formulation effect research, and so on are examples of phase I investigations. It will also provide information regarding the product’s cardiac toxicity to some extent.

Phase 1 Studies on IMPs/NCEs

Our facility / units are well equipped with all required equipment,
including cardiac monitors with a centralized cardiac monitoring system and defibrillators (for emergency).

  • First in humans.
  •  A single ascending dosage trial was conducted.
  • Multiple ascending dose research
  • Single-dose pharmacokinetics
  • Pharmacodynamics of repeated dosages
  •  The relative bioavailability of different formulations
  • Absolute bioavailability (when administered intravenously)
ICBio has highly knowledgeable, experienced, and trained staff who can manage complex phase 1 studies. ICBio even provides master protocol services, in which several objectives may be met in a single protocol, saving time and money on protocol approval.

Phase 1 Study in Patients

Phase II to Phase IV Clinical Trials

  • To ensure patient safety, our clinical trials team assists our clients with study feasibility, pre-site qualification, Site initiation, interim monitoring, and study closure visits, patient recruitment services, site management services, and study monitoring (including Central Monitoring, Remote Monitoring, and On-site Monitoring).
  • Our well-trained and skilled Project Managers, Senior Clinical Research Associates, Clinical Research Associates, and Clinical Trial Assistants have worked with over 350 clinical investigators and have years of clinical monitoring expertise in a variety of therapeutic areas. Our project managers have a successful track record of completing trials on time and within budget. ICBio has completed various Phase II and phase III clinical trials.
  • ICBio has experience of handling studies in various therapeutic segments-
  • Oncology, Psychiatry, Dermatology, Rheumatology, Gastroenterology, Cardiology, Ophthalmology, ENT, Gynaecology, etc.
drug development


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