Our services - from small study to Asian trial
iQ is your best partner in the most effective way of conducting clinical study in Asia
Pre-clinical studyUsing Taiwan site’s state-of-the-art facilities, we offer you an advance solution for pre-clinical study. Our services guarantee fast turnaround time that will help you make your go/no-go decisions faster while reducing your preclinical study costs.
- Transnational medicine
Regulatory Affairs ConsultationIf you are planning to develop your products in Asian countries, we can help you from the first step – searching market trends, until completion of a clinical trial. We have offered a wide range of regulatory consultation with our local know-how.
- Identifying market trends through specialist's hearing
- Developing market development strategy and strategic planning to regulatory affairs either regionally or globally
- Providing regulatory consultation for approval of clinical trials and marketing products
- Establishing products concepts and alliance
- Supporting related consultation for latest generic product
Fist in Human / Phase I Facility/ Proof of Concept StudyMore than 320 phase I studies have been completed by our Taiwanese site since 2004, iQ is a leading CRO/SMO in Taiwan. We are equipped to extensive database of healthy volunteers in rich recruiting environments and employing highly-skilled and experienced staff using disciplined processes to give you the highest accuracy and data integrity. Wide ranges of analysis are available including
- First-in-Human Studies (selected study)
- Bioavailability/Bioequivanence Studies
- Safety & tolerability
- Formulation assessments
- Single dose and multiple dose
In Country Clinical Ceretaker / IND folderEven if you do not have your branch in target countries, we can act as your local representative ensuring compliance with regulatory requirements governing sponsor-investigators.
- Established SOP to function as ICCC / IND folder
- Management of Clinical Trial Notification
- Importation and review of IMP quality
- ADR reporting
- Local representation to work with competent authorities
- Legal representative in Japan, Korea, China and Taiwan
Feasibility study / Study start-up activityFeasibility study helps identifying appropriate countries and investigational sites that provide you the access to patient population required for your study. We can help designing an effective feasibility study through an extensive local network with our local intelligence.
- Good connection to local KOL and related investigator over various therapeutic areas
- Development of synopsis, protocol, investigator Brochures, Informed Consent form
- Conduction of site selection and hospital contract
- Preparation of IND dossier to submit competent authority
- EC/IRB submission
MonitoringThe Study Monitoring Group at iQ Pharma Services consists of well trained and experienced CRAs who conduct site management and monitoring according to the applicable guidelines and laws. They have vast experience in monitoring clinical studies for new pharmaceutical compounds and medical devices. The monitoring services can be precisely conducted base on your requirements.
Data Science/ Medical writingIn order to offer a consistent service from case report form (both EDC/paper) design to the timely release of statistical dataset, data management and statistical group are combined. Having several selections of EDC systems and processing sites, we can offer flexible under your budget.
- Data capturing – importing clinical data and IWRS
- Computerized system validation(CSV)
- Data management - meeting 21CRF Part11 and ER/ES
- Thesaurus coding
- Generation of dataset (CDISC, ADS)
- Statistical analysis and CTD/eCTD generation
Our medical writing group can help you produce a wide range of medical or scientific documentation.
- Development of Protocol, IB, Informed Consent Form
- Publishing CSR/CTD/eCTD
- Organizing Data Safety Monitoring Board (DSMB)
Drug Safety/ Medical affairesOur safety team works closely with CRAs and regulatory team to ensure patient safety to meet regulatory requirements. All AEs and SAEs are followed by timely report in compliance with local authority.
- Reporting and management of AEs and SAEs
- Generation of CIOMS report
- Coding clinical data to a standard set of MedDRA
- Reconciliation of clinical/safety data and AE/SAEs
- Offering 24-hours medical monitoring service
IP ManagementWe can recommend several logistic/IVRS/IWRS vendors depending on your location and requirements and manage these vendors. For the logistical support, iQ ensures that all your study material is available in time at the designated location. IP is well stored under highly temperature control on each country.
Clinical Trial Rescue ServiceYou might have encountered operational issue in the course of clinical trial; iQ’s expert can help analyzing the problem and provide corrective action with our local intelligence and work through extensive network of KOL.
- Issue analysis and solutions through local network
- Study management oversight
- Site auditing and monitoring
- Data review and analysis
- Corrective and preventive action plan and implementation
Other studiesWe can design and conduct various types of studies using our capability. Please contact us for:
- Phase I/II study
- Phase IV/ PMS study
- BA/BE study
- PK study
- Bridging study
- New indication study
- Observational study