PHASE 1 SOLUTIONS, LLC

From Beginning to end We Provide Early Phase Clinical Research Services: Placement, Study Management, GCP Compliance, Regulatory Compliance, ensuring data accuracy/integrity and Oversight Services.

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EFFECTIVE COLLABORATION

OUR MISSION:

To provide highly specialized expert Management and Operational Services for Early Phase/Phase 1 Clinical Trials to ensure patient participants and volunteers are safe, through customizable collaboration with sponsors around the world developing products that save and improve lives.

HOW: Employing flexible business models.

: Part of your strategic Outsourcing plan

: Engaged as your strategic Partner

PRE-CLINICAL SERVICES

We stand with you and take the lead in getting your New Molecular Entity (NME)/Candidate Compound/Biologic/Biosimilar, Biopharmaceutical, Regenerative Medical Product or Phase 1 Study into the Clinic. We are your navigator from laboratory through the various Regulatory requirements, and ensuring the proper documents and documentation are in place.

PHASE 1

TRANSLATIONAL MEDICINE/FIRST IN HUMAN/CLINICAL PHARMACOLOGY SERVICES

WE ARE YOUR PHASE 1 DEPARTMENT, AN EXTENSION OF YOUR EXISTING EARLY PHASE TEAM OR YOUR PHASE 1 TEAM OUT-RIGHT. FIT FOR YOUR PURPOSE. WE LOCATE PHASE ONE UNITS (CPUs), CONDUCT YOUR RFP/BID DEFENSE AND AWARD PROCESS, PLACE STUDIES, MANAGE THE SET-UP, OVERSIGHT OF CLINICAL CONDUCT, TAKE CARE OF YOUR SAMPLE MANAGEMENT, PREPARE FOR AND EXPEDITE DOSE ESCALATION MEETINGS REPORTING THOSE DECISIONS TO ETHICS/IRB, MONITOR AND CONDUCT SDV UP THROUGH DBL AND FACILITATE REPORT WRITING OF YOUR FIH AND CLINICAL PHARMACOLOGY STUDIES.

OUR PHILOSOPHY IS EARLY PHASE CLINICAL TRIALS ARE UNIQUE OPERATIONALLY AND SHOULD NOT BE CONDUCTED ENTIRELY LIKE LATER PHASE STUDIES ARE CONDUCTED. WE ARE EXPERTS IN ALL MANNER OF PHASE 1 OPERATIONS AND MANAGEMENT: SAFETY FIRST, EFFICIENTLY RUN STUDIES, HIGHEST DATA QUALITY, ON SCHEDULE AND ON BUDGET

OUR GEOGRAPHIC SERVICE AREA

USA

APEC MEMBER COUNTRIES

PMDA AFFILIATED STRATEGIC PARTNER COUNTRIES (FOR REGENERATIVE MEDICINE PROJECTS)

Partnering with BIOPHARMACEUTICAL COMPANIES, CROs and SPONSORS: providing Study Management Services for Phase 1 Clinical Trials (OVERSIGHT, PROJECT MANAGEMENT AND ICH E6 R2)

PROJECT MANAGEMENT FOR TRANSLATIONAL MEDICINE AND CLINICAL PHARMACOLOGY STUDIES

For First In Human

SAD

MAD

PH1b

For Clinical Pharmacology

DDI

ADME

TQTc

rBA/BE

FOOD EFFECT

BRIDGING

RENAL

HEPATIC

HUMAN ABUSE LIABILITY

TRAINING SERVICES

Training of experienced CRAs and Study Managers specifically for Phase 1 Clinical Trials and those transitioning into Phase 1. Providing initial training for those wanting to/needing to transition into a STEM related career.

Employment Services

Providing employment services to experienced CRAs