Clinical Research & Safety
ICG Medical’s clinical development services cover many aspects of research, from individual Phase I studies to Phase IV programs. We work across many therapeutic areas and have experience with a wide range of product types.
We can take full responsibility for a project, from protocol design, study coordination, data management and statistical analysis, right through to the completion of the final clinical study report. Our staff is experienced in partnering and establishing relationships with clients and managing third-party vendors to create a fully integrated project team.
We offer stand-alone services, such as project management, monitoring or safety review, giving you the exact level of support you need to ensure a successful outcome.
Summary of Services
- Project management
- Monitoring and site management
- Phase I to IV program management
- Pharmacovigilance and medical monitoring
- Safety review
Drug Safety and Pharmacovigilance
Our drug safety and Pharmacovigilance team partners with clients to develop and implement pharmacovigilance strategies. We understand our clients’ commitment to product stewardship and their need for rigorous programs that meet regulatory requirements and protect patients.
We offer integrated services to help you develop and implement safety and surveillance programs for your products. We routinely collaborate with pharmaceutical and biotech companies, generic drug manufacturers and clinical research organizations (CROs) to provide Pharmacovigilance and Medical Monitoring services.
Pharmacovigilance Services: We provide a comprehensive plan to help you manage your pre- and post-marketed product safety program. Our services include:
- Adverse event (AE) and serious adverse event (SAE) data entry and logging
- Current treatment utilization patterns
- Disease burden and prevalence
- Generation of MedWatch 3500A/CIOMS I forms
- SAE narrative writing
- Physician medical review and signal detection
- Literature reviews and summaries
- AE and SAE logging, tracking, coding, and case processing
- MedDRA and WHO-DD coding
- Generation of MedWatch 2500A/CIOMS I forms
- Preparation of periodic safety update reports (PSURs) and periodic adverse drug experience reports (PADERs)
- Prompt notification of potential expedited IND, alert, and suspected unexpected serious adverse reaction (SUSAR) reports
Medical Monitoring: Our medical monitoring services are provided by licensed physicians who have extensive experience in clinical development and review of SAE and AE cases and can provide expert support throughout clinical development and post-marketing. Our services include:
- Coverage by licensed physicians
- Assessing subject eligibility
- Evaluating study protocols and informed consents
- Analyzing and reporting serious adverse events (SAEs)
- Tracking participants’ safety throughout the trial
- Assessing the benefits and risks on an ongoing basis
- Identifying safety signals and safety trends
Our experts can help you evaluate your product’s safety in clinical and post-marketing studies. We are committed to excellence and focus on real-world results and your satisfaction. Our team can help you effectively develop your safety management program and ensure regulatory compliance, so you can be confident your company is protecting its patients, study participants, and reputation.