Marianna Tcherpakov is the Business Development Manager of Bioserv Corporation, a U.S. boutique cGMP contract manufacturing organization (CMO) specialized in aseptic, non-aseptic, and high-potency...
Sandeep Singh is the Vice President of Clinical Operations at CBCC Global Research, a contract research organization offering a wide variety of clinical research services to advance clinical...
Tzippi Cohen Aharonson is the CEO and Founder of TCA Clinical Research Ltd., a privately owned Israeli clinical research organization (CRO) with more than 20 years of experience managing clinical...
Dr. Manoj Jadhav, PhD, FCP is a Translational Clinical Pharmacologist and the Founder and CEO of ISHA Therapeutics, a New Jersey-based company specialized in supporting biotech and pharma companies...
Sofpromed is a clinical research organization (CRO) providing cutting-edge clinical data management, biostatistics, and statistical programming services in SAS for phase I-IV clinical trials across...
Are you looking for clinical data management service providers for clinical trials conducted in the United States? IQVIA, Quanticate, Syneos Health, Linical, eClinical Solutions, ICON, and Sofpromed...
Are you looking for biostatistics and statistical programming service providers for clinical trials executed in the United States? PPD, Veristat, Cytel, Catalyst, StatsMetrika, SCiAN, and Sofpromed...
Israel is a popular country to conduct clinical trials. Are you looking for clinical research organizations (CRO) managing clinical trials in Israel? Here you can find a complete list of full...
Click here to request a detailed quotation for drug packaging, labeling, storage, and distribution services in a clinical trial. The cost of packing, labeling, storing, and distributing a drug...
Click here to request a detailed quotation for the manufacture of a drug product batch for your clinical trial The cost of manufacturing a drug product batch is an important factor when calculating...
Pharmaceutical formulation is an important challenge faced by biotech companies developing new drugs to be tested in first-in-human (FIH) clinical trials. Formulation development is a fundamental...
Contact us at info@sofpromed.com if you need an EDC system for your clinical trial. An electronic data capture (EDC) system —also referred to as electronic case report form (eCRF)— is a very...
Click here to download a fully detailed Electronic Case Report Form (eCRF) quote An Electronic Case Report Form (eCRF) software —also known as Electronic Data Capture (EDC) system— is an essential...
Post-approval studies —also known as postmarketing or post-authorization studies— are important clinical studies conducted by biotech and pharma companies once a drug has obtained a marketing...
The quality section of the Investigational Medicinal Product Dossier (IMPD) —which deals with the chemistry, manufacturing, and controls (CMC) of a drug— is a very critical factor to have a clinical...
Biotech and pharma companies planning clinical trials in Europe will have to submit a clinical trial application (CTA) to the national regulatory authorities of the countries in which the clinical...
Michael Loftus is the Executive Director of Integrium Clinical Research, a clinical CRO headquartered in California, United States, specialized in executing phase I, II, III, and IV clinical trials...
This article explains how to develop a per patient clinical trial budget (test, procedure, and staff costs to be paid to the hospital for each recruited subject). If you want to download a free (per...
U.S. biotech companies often have the need of conducting clinical trials in Europe. Planning clinical studies in the European Union poses several operational and regulatory challenges, like finding...
Biotech and pharma companies conducting clinical trials in Europe —with a drug product (DP) manufactured in a non-EU country— will need a Qualified Person’s (QP) Declaration when submitting the...