• Trial Design and Management: We work closely with sponsors to design and manage clinical trials from protocol development to post-study analysis, ensuring alignment with your objectives.
• Participant Recruitment: Our strong track record in recruiting diverse populations ensures that clinical trials are inclusive and reflective of the real-world patient population.
• Regulatory Compliance: We ensure that every aspect of the trial complies with all applicable ethical standards and regulations, maintaining data integrity and participant safety.

• Compliance Certifications: BCTA follows FDA, HIPAA, and Good Clinical Practice (GCP) guidelines, ensuring trials are conducted with the highest standards of quality and ethical compliance.
• On-site Laboratory: Our CLIA-certified laboratory ensures that all regulatory-compliant laboratory testing is performed with precision.
• Audits and Monitoring: Continuous internal audits and real-time monitoring ensure that trials meet all applicable standards and compliance requirements.

• Diverse Population Access: BCTA has access to a large and diverse patient base, ensuring trials meet demographic diversity requirements.
• Outreach and Engagement: We use targeted outreach campaigns and local community engagement strategies to ensure quick and efficient participant recruitment.
• Retention: Proven methods are employed to ensure participant retention throughout the trial duration, reducing dropout rates.

• High-Quality Data: Our trials yield reliable and high-quality data, thanks to our rigorous processes.
• Recruitment Success: Strong recruitment capabilities, particularly in diverse populations.
• Dedicated Support: A dedicated team supports sponsors throughout the trial process, ensuring seamless communication and efficient trial management.

Bay Clinical Trials Associates has had the privilege of partnering with leading pharmaceutical and biotech companies. Our collaborations with these valued partners demonstrate our experience in delivering high-quality clinical trial services.

Our Valued Partners:

• Apnimed
• GSK
• Abbott
• AbbVie
• Amgen
• Karuna Therapeutics
• Shionogi
• Ocugen
• Merck
• Pfizer
• XBiotech

"BCTA has been a critical partner in our clinical trials, consistently delivering high-quality data and meeting recruitment targets efficiently." – Sponsor A

"Their team is highly professional, responsive, and truly invested in the success of our studies." – Sponsor B

Partnership Process:

1. Initial Consultation: We begin by understanding your needs and trial goals.
2. Proposal Development: Our team drafts a detailed proposal outlining timelines and cost estimates.
3. Onboarding: We ensure a smooth onboarding process to kickstart the trial.
4. Ongoing Communication: Expect regular updates and collaboration throughout the trial lifecycle.

Contact Information: Reach out to our partnership team to explore how Bay Clinical Trials Associates can support your clinical trial needs.

BCTA is equipped to conduct clinical trials in a wide range of therapeutic areas, ensuring expertise across multiple specialties:

• Allergy
• Cardiology
• Dermatology
• Endocrinology/Metabolic Systems
• Gastroenterology/Hepatology
• Hematology
• Immunology
• Infectious Disease
• Nephrology
• Neurology
• Oncology
• Ophthalmology
• Podiatry
• Pain & Orthopedics
• Psychiatry/Psychology
• Pulmonology/Respiratory
• Rheumatology
• Sleep Medicine
• Urology
• Vaccines
• Women's Health

At BCTA, we have a highly qualified team of specialized staff dedicated to ensuring the success of your clinical trial:

• Certified Clinical Research Coordinators (CRCs): All CRCs are fully trained and certified in CITI/GCP & IATA, ensuring global compliance with clinical research standards.
• Site Director: Oversees the overall operations of clinical trials, ensuring smooth workflow and protocol adherence.
• Regulatory Coordinator: Responsible for ensuring compliance with regulatory requirements, handling submissions, and maintaining communication with IRBs.
• Dedicated Recruitment Specialist: Focuses on recruiting diverse participants and maintaining retention throughout the trial.
• Laboratory Technicians, Pharmacists, and Pharmacy Technicians: Our lab staff ensures high-quality lab services, while our pharmacists manage investigational product dispensation and storage.
• Data Entry Specialists: Ensure timely and accurate data entry into clinical databases.
• Phlebotomists: Certified professionals handling all blood draws and sample collections.
• Raters: Specialized staff responsible for administering rating scales for clinical assessments.
• Infusion Nurses: Manage intravenous treatments and monitor patients during infusions.
• Medical Directors: Board-certified physicians providing oversight and medical expertise throughout the trial.

BCTA offers state-of-the-art equipment and fully equipped facilities to support the efficient conduct of clinical trials:

• Refrigeration and Freezing Capabilities: We maintain -20°C and -80°C freezers, as well as standard refrigeration, to ensure proper sample storage and temperature-controlled environments for sensitive investigational products.
• Diagnostic Equipment: Our facilities are equipped with advanced diagnostic tools, including:
  • ECG (Electrocardiogram)
  • DEXA (Dual-Energy X-ray Absorptiometry)
  • PET Scan (Positron Emission Tomography)
  • MRI (Magnetic Resonance Imaging)
  • CAT Scan (Computed Axial Tomography)
  • Fibro Scan
  • X-Ray
  • Ultrasound
• Infusion Pumps and Emergency Equipment: Our infusion unit is fully equipped with infusion pumps for precise drug administration. An emergency crash cart is readily available for patient safety.
• On-site Pharmacy and Drug Storage Monitoring: BCT has an on-site pharmacy that is secure and temperature-controlled, with daily monitoring of drug storage conditions to ensure compliance with investigational product requirements.