Clinical Services

1

Feasibility & Start-up

Country/site feasibility, regulatory strategy, EC/IRB submissions, contracts & budgets

2

Project Management

Risk-based planning, vendor oversight, KPIs, governance and communication

3

Site Management & Monitoring

On-site/remote monitoring, RBM, query resolution, TMF management

4

Patient Recruitment & Retention

Strategy, digital outreach, site/community partnerships, referral networks, diversity plans, and retention programs

5

Data Management

EDC build, data cleaning, medical coding, data review and listings

6

Biostatistics & Programming

Stats plans (SAP), SDTM/ADaM, TLFs, PK/PD analyses

7

Medical Writing

Protocols, IBs, Informed Consents, CSRs, manuscripts

8

Regulatory Affairs

Health authority interactions, submissions, responses and inspections

9

Pharmacovigilance & Safety

Case processing, medical review, SUSAR/DSUR, signal detection

Therapeutic Areas & Indications

Oncology

Breast (HR+/HER2-, TNBC), Colorectal (CRC), Lung (NSCLC/SCLC), Prostate, Melanoma, Hematologic (CLL/AML)

Neurology

Alzheimer’s disease, Parkinson’s disease, Major depressive disorder, Schizophrenia, Epilepsy, Neuropathic pain

Endocrinology & Cardiology

Heart failure (HFrEF/HFpEF), Atrial fibrillation, Hypertension, Dyslipidemia, Type 2 diabetes, Obesity