Comprehensive Biorepository Specializations and CRO Services – The Key to Effective Research Management

Comprehensive Biorepository Specializations and CRO Services – The Key to Effective Research Management

Effective CRO services act as a vehicle to streamline research efforts. One of the many priorities of effective CRO management assists in getting our tissues to market. Avoiding costly mistakes, facilitating the transition between clinical phases, and working in tandem with FDA objectives are a few of the benefits of outsourcing CRO to proven professionals. 

About Geneticist’s Clinical Research Organization Services (CRO) 

Geneticist is a premier biorepository that offers CRO services in Eastern Europe as one of our service specializations. Partnering with us includes tapping into our vast knowledge of the biotech industry standards. We excel in our ability to oversee and optimize the clinical protocol process.

Our suite of CRO services include:

    • Working with the Clinical Investigator

    • Strategies for Quality Controls

    • Development of SOP

    • Implement Cost-Saving Measures

    • Adherence to FDA & HIPAA Requirements

    • Overseeing of Regulatory Submissions and Adverse Reaction Reporting

Does Geneticist Offer CRO Services in Eastern Europe?

In addition to our tissue banking services, Geneticist provides expansive CRO services in the Eastern European Continent. We deliver quality comprehensive study design services that cover the following areas of medicine and research: 

    • Oncology

    • Hematology

    • Cardiovascular

    • Auto-Immune Disorder

    • Genetic Discoveries

Geneticist pairs our biorepository services with those of CRO management as we find it helps facilitate research efforts and provides an added layer of quality control. Our clinical professionals hand-hold the entire clinical process from tissue collection, distribution, and management all the way through to designing the ideal clinical study protocol ideal for the trial objectives. 

Our biorepository maintains an impressive portfolio and suite of successful completed clinical trials. We hold an impressive track record of audit free trials and easy movement between trial phases. Our scientific staff is adept at clinical laboratory practices making our firm ideal to facilitate the adherence aspects associated with flawless study design principles.

The Importance of Quality CRO Services Throughout the Entire Clinical Trial Phase

The clinical trial process is a multi-layered entity. Each layer of the clinical trial process hinges upon a well-planned foundation. From inception to completion, Geneticist understands the need for careful end-to-end CRO management. The aim is to reach the end clinical process error-free and without compromise to the research objectives. 

Geneticist expertly guides each component including: 

    • Study Trial Design 

    • Patient Recruitment

    • Patient Engagement

    • Study Coordinators

    • Study Reporting 

    • Regulatory Management

    • FDA Partnership and Adherence

    • Adverse Effect Reporting

    • Clinical Report Evaluations

    • Submission Reports

    • Quality Control and Audits

    • Phase Development and Execution

    • Modification

    • Results and Findings

    • Medical Writing


Why Consider Outsourcing CRO Services with a Biorepository Company?

In addition to the above chief elements of clinical trial management, we offer a vast amount of CRO services that have helped establish Geneticist as one of the leading biorepository firms available. We take into consideration a few trending elements that play a vital role in all research projects. 

Inclusion and Diversity. In an effort to better coordinate with study investigators and CRA’s, Geneticist offers on-site monitoring, integrated specimen collection, and intermittent diagnostic capabilities. We oversee all patient monitoring, safety, and engagement, but also offer insight as to how to fill in study recruitment genres to offer the best research results available. 

The Development of Custom Assays. Designing biosamples tailored to meet the needs of each particular study criteria element. This is an important benefit because efficacy in tissue handling and banking will eliminate false study results and corrective issues obtained during audits. Study results depend upon the adherence to quality controls and SOP. We are also can provide training, equipment and supply needs, and specimen storage. The integration of all these core services by our team can help offset costs and timely setbacks. 

CRO Outreach. Communication efforts can determine how smooth the clinical process can go. We have found one of the biggest failures to conclude a study lies within communication efforts. This communication effort is best seen at the clinical monitoring site for reporting of adverse effects, informed consent paperwork, pharmacologic study reporting, and also IRB reports. What we have learned is that these crucial components are best accomplished by many incorporating many checks and balances. 

Technology. Geneticist operates within the latest scope of Medidata applications and cloud computing. Technology and CRO services go hand-in-hand and cover document management, record management, communications, recruitment, social media platforms, and laboratory compliance. Global experience and knowledge of the current technological interfaces is a plus your organization can’t afford to ignore. 

Conclusion

Geneticist proudly circles the entire vision of CRO operations and management. From implementation, design, tissue banking and storage – our scientific professionals are on the pulse of all research culture and function. Contact us today to find out more about how our repository can assist your research team today.