Site Infastructure

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Access to examination rooms, procedure rooms, diagnostic labs, and treatment areas that ensures smooth participant management. 

Availability of an on-site pharmacy with capabilities for storing, dispensing, and managing investigational products, including secure storage for controlled substances 

In-house or partner labs equipped for sample processing, storage, and shipping, with capabilities to handle various types of biospecimens. 

Access to Electronic Medical Records (EMRs) and Clinical Data Management Systems (CDMS) for efficient data capture, monitoring, and reporting. 

Availability of specialized equipment like ECG machines, imaging devices (X-ray, MRI, CT), and centrifuges for blood processing

Experienced PIs with relevant therapeutic area expertise and a track record of leading clinical trials. 

Dedicated and trained coordinators experienced in handling study protocols, regulatory compliance, participant management, and data entry. 

Contracted Nurses skilled in clinical trial procedures, patient care, and protocol adherence. 

Personnel experienced in handling investigational products and biospecimen processing.

Access to a large, diverse patient population through EMRs research      database, patient registries, or community partnerships for efficient recruitment.

Capability to use various recruitment strategies such      as online platforms, community outreach, and partnerships with local healthcare providers.

Programs and support systems to keep participants engaged and reduce dropout rates, such as flexible scheduling, regular follow-ups, and patient  

Expertise in regulatory requirements (FDA, ICH-GCP, IRB) with a dedicated regulatory affairs team to handle submissions and approvals.

Established Standard Operating Procedures (SOPs) for data integrity, protocol adherence, adverse event reporting, and quality assurance checks.

Internal auditing processes to ensure compliance and readiness for external audits.

Demonstrated experience in conducting, trials in specific therapeutic areas (e.g., Otology/Neurotology (Ear Disorders), Rhinology, Laryngology, Respiratory) with access to relevant patient populations.

Collaborations with hospitals, clinics, or relevant institutions for multi-site trials and access to specialized expertise.

Offering additional support like transportation, language translation, and counseling to enhance the patient experience and improve retention.

Ensuring that participants are fully informed and educated about the trial process, risks, and benefits.