Research pharmacy and clinical trial infusion services.

Two integrated capabilities, one facility

Most research sites offer either investigational drug services (pharmacy) or clinical trial infusion administration (site of care) — not both. TheraVite is unusual: we are a licensed specialty pharmacy and a state-of-the-art ambulatory infusion center, operated by the same integrated clinical team.

That means sponsors and CROs can contract TheraVite for pharmacy IDS only, infusion administration only, or both under a single agreement — with the operational efficiency of a single vendor, single point of contact, and single set of quality systems.

Track 1: Research Pharmacy Services (IDS)

TheraVite’s licensed pharmacy provides Investigational Drug Services (IDS) — protocol-driven receipt, storage, preparation, dispensing, and reconciliation of investigational product, executed under Good Clinical Practice with the documentation discipline sponsors and regulators expect.

Research pharmacy services are delivered by pharmacists trained in GCP, sponsor protocol compliance, blinding controls, and investigational product handling. Services are contracted per study or per program — distinct from commercial specialty dispensing, and distinct from our advisory Consulting engagements.

Sponsors and CROs work directly with a designated TheraVite research pharmacist who owns the protocol from site initiation to close-out — not a rotating case queue.

Investigational product receipt & reconciliation

Verified against shipping manifests at receipt, with immediate temperature-excursion review, chain-of-custody documentation, and sponsor notification workflows. Quantities, lot numbers, expiration dates, and kit assignments are recorded to source records and cross-referenced against the study drug accountability log.

Storage across all temperature ranges

Ambient (15–25°C), refrigerated (2–8°C), and frozen (−20°C) storage with continuous 24/7 temperature monitoring, redundant monitoring systems, and after-hours alerting. Secured, access-controlled storage areas segregated from commercial pharmacy stock. Locked storage boxes available for research product. Temperature logs available upon request. Excursion management SOPs with documented investigation, sponsor notification, and product quarantine.

Protocol-specific dispensing

Dispensing per the sponsor-approved pharmacy manual, including complex regimens, dose modifications by cycle, weight-based or BSA-based dosing calculations, dose interruptions and reductions, and prescribing information adherence checks. Every dispense linked to a specific subject, visit, and protocol version.

Blinding & unblinding support

Protection of study blind through workflow controls, physical separation of blinded materials, restricted-access unblinding systems, and pharmacist training. Emergency unblinding procedures on record, tested, and available 24/7 with documented sponsor and IRB notification protocols. Interactive Response Technology (IRT / IWRS) integration for randomized studies.

Drug accountability & chain of custody

Auditable records of every unit received, dispensed, returned, and destroyed. Real-time drug accountability logs reconciled at each monitoring visit and at study close-out. Source documentation ready for monitor review at any point in the study lifecycle.

Sterile & non-sterile compounding and preparation

Preparation of investigational product per protocol, including reconstitution, dilution, admixture, and repackaging. Sterile preparations are compounded as USP <797> Category 1 Compounded Sterile Preparations in a Segregated Compounding Area with an ISO Class 5 primary engineering control, environmental monitoring, and documented personnel competency. Non-sterile preparations are handled per USP <795>. Preparation logs, beyond-use dating within applicable Category 1 limits, and quality checks documented per sponsor and regulatory expectations.

Return, quarantine, and destruction

Returned investigational product tracked, quarantined, and reconciled prior to sponsor-directed return or destruction. Documented destruction with certificates. Full documentation trail from receipt through final disposition.

Sponsor site visit & monitor support

Pharmacy documentation, source records, and staff availability for site initiation visits (SIVs), routine monitoring visits, remote monitoring, and close-out visits (COVs). Pharmacy walkthrough, temperature record review, drug accountability reconciliation, and staff Q&A supported without disruption to routine operations.

Audit & inspection readiness

Ongoing compliance with ICH E6(R3) Good Clinical Practice, FDA 21 CFR Part 312, sponsor SOPs, and site-specific quality standards. Pharmacy documentation maintained inspection-ready at all times; not reconstructed at audit request.

Track 2: Clinical Trial Infusion Administration

TheraVite’s ambulatory infusion center serves as a strategic extension of sponsor and investigator research teams, offering protocol-driven administration of infusion-based investigational products. Each trial infusion is prepared and administered by our clinical nursing staff in collaboration with sponsor physician-investigators and research coordinators.

This capability is available as a standalone service for sponsors already partnered with a pharmacy for IDS, or as part of a combined pharmacy-plus-infusion contract with TheraVite.

Medication classes routinely administered

TheraVite’s infusion nursing team has experience across a wide range of infusion product classes, including but not limited to:

• Monoclonal antibodies
• TNF-alpha inhibitors
• Immune globulin therapies (IVIG, SCIG)
• Enzyme replacement therapies
• Alpha-1 proteinase inhibitors
• Bisphosphonates
• RNAi agents
• Biosimilars and novel biologics
• Supportive care and hydration therapies

Aligned with our commercial therapeutic focus areas of rheumatology, gastroenterology, neurology, hematology, oncology support, and rare disease.

Facility features

• Private and semi-private infusion suites for physical examination and study product administration
• Comfortable, patient-centered environment designed to support long infusions and repeat visits — reclining chairs, blankets, Wi-Fi, streaming, refreshments
• On-site pharmacy area integrated with the infusion suite for investigational product preparation
• Monitored temperature-controlled storage — refrigerated (2–8°C), ambient (15–25°C), frozen (−20°C)
• Access-controlled research product storage with locked boxes segregated from commercial stock
• Located within close proximity to major regional hospitals for continuity of care and emergency backup
• Ample free parking to reduce visit friction for enrolled subjects
• ADA-accessible facility throughout

On-site clinical equipment

• Infusion pumps (including programmable and volumetric)
• Continuous vital signs monitoring
• Electric scale
• EKG machine (12-lead)
• Oxygen supply and delivery
• Zoll Medical AED and defibrillator
• Emergency medications and reversal agents on-site
• Centrifuge (for on-site sample processing where protocol requires)
• Eye wash stations
• Calibration documentation available on request

Clinical staff and credentials

• Experienced infusion nurses with backgrounds in specialty and biologic administration
• PharmD oversight of every investigational product preparation and dispense
• GCP certification available and maintained for research-facing staff
• Board-certified advanced practice providers available for protocol-required assessments where applicable
• Multidisciplinary care team coordinating with sponsor investigators, research coordinators, and monitoring visits

Coordination with sponsor teams

TheraVite’s trial infusion services function as an extension of the sponsor’s clinical operations. Our staff coordinates directly with sponsor-designated physician investigators, research coordinators, and monitors — supporting protocol-specific procedures, subject visit windows, adverse event workflows, and source documentation requirements.

How engagements are structured

Sponsors and CROs can contract TheraVite for any combination of the following:

• Pharmacy IDS only — receipt, storage, preparation, dispensing, accountability
• Trial infusion administration only — site-of-service for infusion-based investigational products
• Combined pharmacy + infusion — end-to-end handling from receipt to bedside under a single agreement

All engagement types follow a three-component budget structure:

1. Setup — protocol review, pharmacy manual review, SOP alignment, staff training, IRT setup, site initiation participation, budget finalization.
2. Operational support — per-subject or per-visit fees covering dispensing, administration, documentation, monitoring visit support, and ongoing accountability.
3. Close-out — final accountability reconciliation, return/destruction, source document archival, and close-out visit support.

Budget estimates are provided at protocol review and reconciled at study close. Complex protocols may require additional line items for specialized preparation, extended administration windows, or expanded accountability requirements.

What this is not

TheraVite’s research pharmacy and trial infusion services support investigational drug operations and administration at the pharmacy and site-of-care levels. TheraVite does not conduct clinical trials as a Contract Research Organization (CRO), does not enroll subjects, does not serve as a Principal Investigator, and does not act as an Institutional Review Board (IRB). Sponsors seeking advisory support for regulatory strategy, IND submissions, pharmacy manual development, or IDS setup should visit our Consulting page — consulting engagements and operational research pharmacy or infusion services are contracted separately.