Early-Phase Clinical Studies Worldwire

Because your product's benefit potential is what matters

Many innovative products might not reach the market because of the wrong reasons. In order to cut costs, fledging, innovative companies in-source all the development. However, the high costs of funding the learning curve of Clinical Studies take its toll on the company and, ultimately, on the product's chances of reaching the market.

WE STRONGLY BELIEVE THAT A GOOD PRODUCT THAT WILL BENEFIT PATIENTS WORLDWIDE, DESERVES THE SAME OPPORTUNITIES TO SUCCEED REGARDLESS OF THE SIZE OF YOUR COMPANY OR IT'S FINANCIAL WEALTH.

Total Management Service of Early-Phase Clinical Studies
To maximize your product's chances of overcoming the saddle between late pre-clinical to early clinical development, we provide the following consulting services:

• Clinical Development Strategy
• Medical writing of protocols, Informed Consent Forms, CRFs, SOPs, etc.
• Building in-house infrastructure to handle Investigational product's aspects

Once these preliminary stages have been completed, we support your product's development with our Clinical Trials Management, ICH-GCP compliant services:

• Pre-study site selection for sites and investigators
• Essential document QA checks and retrievals
• Contracts and budget negotiation
• Adaptation of submission documents to local regulations
• Submission of studies to local IRBs and regulatory authorities
• On-site initial and ongoing training
• All study-specific logistics at a national level
• SITE MANAGEMENT and MONITORING
• Pharmacovigilance-related activities
• Data cleaning and retrieval
• Ongoing communication with local IRBs and local regulatory authorities (when required)
• Close-out visits and study closure
• Handling of audits and inspections at a national level
• Archiving of local study-related documentation

We tailor a management and monitoring suite for budget optimized, successful Early-Phase Clinical Trials