For Sponsors & CROs

• Clinical Trial Management
  Full-service management of Phase II–IV studies from startup to closeout.

• Rapid Study Start-Up
  Regulatory submissions, IRB coordination, and contract/budget negotiations.

• Patient Recruitment & Retention
  Targeted outreach and community engagement to ensure enrollment goals are met.

• Experienced Pulmonary Focus
  Special expertise in asthma, COPD, ILD, CTD-ILD, bronchiectasis, lung infections, pulmonary hypertension trials, metabolism & obesity studies, sleep studies, among others.

• Data Integrity & Compliance
  Use of eSource, eReg, and CTMS (CRIO) for streamlined, inspection-ready records.

• On-Site Facilities
  Exam rooms, laboratory, investigational drug pharmacy, secure storage, and private offices.

• Quality Assurance
  Adherence to GCP, FDA, and ICH guidelines with strong SOP-driven processes.

For Patients & Volunteers

• Clinical Trial Participation
  Access innovative treatments and therapies not yet available to the public.

• Comprehensive Medical Assessments
  Receive detailed physical exams, pulmonary function tests, and health evaluations.

• Close Medical Monitoring
  Our physicians and coordinators provide personalized attention and frequent follow-ups.

• Compensation & Care
  Eligible participants may receive compensation for their time and travel.

• Education & Support
  We ensure participants fully understand study expectations, risks, and benefits.

Pharmacy Capabilities

• Investigational Product Storage: Temperature-controlled, monitored, and secure storage for oral, inhaled, injectable, and infusion therapies.

• Drug Accountability & Compliance: Detailed logs of dispensing, returns, and reconciliation, fully inspection-ready.

• Blinded and Unblinded Dispensing: Ability to support double-blind and placebo-controlled trial designs.

• Infusion & Injectable Preparation: Trained staff for IV, subcutaneous, and inhalation-based investigational therapies.

• Temperature Monitoring & Alarms: Continuous monitoring with documented excursions and corrective actions.

• Regulatory Compliance: Handling in alignment with ICH-GCP, FDA, and sponsor SOPs.

• Collaboration with Investigators: Ensuring proper prescribing, dosing, and patient counseling for investigational products.

Specialized Capabilities

Pulmonary Function Testing (PFTs):

• Spirometry (pre- and post-bronchodilator)

• Forced Vital Capacity (FVC) and FEV1 % predicted

• Diffusion capacity testing (DLCO)

Exercise Capacity & Functional Assessments:

• Six-Minute Walk Test (6MWT)

• NYHA/WHO Functional Class Assessments

• Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)

Cardiac & Hemodynamic Testing:

• 12-lead Electrocardiograms (ECG)

• Echocardiography

• Right Heart Catheterization (including hemodynamic sub-study support)

• NT-proBNP biomarker testing

Imaging & Radiological Assessments:

• High-Resolution CT (HRCT) Scans for lung evaluation

• Quantitative HRCT (qHRCT) and Functional Respiratory Imaging (FRI)

• Chest CT for pulmonary vasculature and lung parenchyma assessment

Study-Specific Advanced Monitoring

• Remote patient diary compliance tracking (BEST diary, COPD diaries)

• Digital cough severity scales, symptom diaries, and patient global impression scales

• Bronchiectasis Severity Index

• St. George’s Respiratory Questionnaire (SGRQ)

• COPD Assessment Test (CAT)

• Quality of Life – Bronchiectasis (QOL-B)

• EXACT-PRO & E-RS:COPD for symptom tracking

• Living with Pulmonary Fibrosis (L-PF) questionnaire

• EuroQol EQ-5D

Central & Local Laboratory

Laboratory & Safety Capabilities:

• On-site blood and urine clinical safety labs

• Serology testing (hepatitis, HIV, autoimmune)

• Pregnancy testing (routine and protocol-specific)

• Advanced biomarker and exploratory pharmacodynamic testing

Biological Sample Collection & Biomarker Analysis:

• Sputum collection for biomarkers and pathogen analysis (including Pseudomonas aeruginosa)

• Serum and plasma biomarker testing (bone metabolism, kidney function, IL-33, sST2, inflammatory markers)

• DNA and genetic banking for pharmacogenomics

• Immunogenicity assessments (anti-drug antibodies, PK/PD analysis)