Your Immunology CRO Partner
ARG Has Extensive Experience To Operationalize Clinical Research
Challenges in Immunology Clinical Trials:
- Does your Contract Research Organization have 15+ years of therapeutic area experience?
- Does your team know the investigators and site staff in the tight-knot immunological space?
- Does your CRO know what to do with an unclear roadmap in a rare orphan disease?
- Do you need specific experience, such as phase I or medical device?
- Has your research experienced issues in patient recruitment and compliance?
- Do you expect a wide range of global clinical trial service capabilities ?
ARG Has The Relationships And Experience To Empower Your Clinical Trial
ARG has strong relationships with leading investigators and coordinators in multiple strategic areas in immunology. Equally as important, our deep expertise, which is rooted in long-tenured project management and clinical operations team members, provides stability when asking questions and solving problems.
ARG has consistently demonstrated the capacity to operate successfully in worldwide clinical trials. Our calm experience allows us to focus on strengthening relationships, gathering facts and opinions, and building trial team solidarity in studies.
“Lessons learned over the years have allowed us to create efficiencies in patient recruitment, protocol design and eCRF database construction.”
“With 15 years in the space, ARG has gathered invaluable experience. We have built strong relationships with the KOLs and PIs conducting these immunological studies. All of this leads to better data. ARG has created a ‘deep bench’ of CRAs & Project Managers trained and experienced in immunology. Additionally, our size allows us to be flexible and nimble when working toward deliverables. All of these attributes make ARG the clear choice for your project.”
A Track Record Of Successful Trial Management
15 YEARS OF EXPERIENCE AS A GLOBAL CRO
OVER 40 STUDIES
Including 13 rescued studies
OVER 500 SITES
Serving 25 countries worldwide
OVER 2000 PATIENTS
With time to first patient of only 15.75 days
50% OF STUDIES INCLUDED PEDIATRICS & PHARMACOKINETICS
ALL PHASES OF DEVELOPMENT FROM PK TO IV
ARG Best Practices in Immunology Trials
Focus on Patients
- Nurtures relationships with immunological advocacy groups
- Innovates with our “Study champion” model
- Understands and addresses human factors
Experience Through Adaptation
- Leverages an ever-expanding network of drug discovery relationships
- Demonstrates the capacity to be effective when no blueprint exists
- Adapts to unique study design and implementation circumstances
Investment In People
- Attracts and retains the most talented people in the industry
- Offers employees meaningful personal and professional development
- Empowers individuals to evolve and take ownership of decisions
Case Study
Patient First Is Central To Recruitment
and Compliance
Atlantic Research Group is currently outlining its plans to utilize what it is calling a “Study Champion.” This role will add another layer of continuity to clinical trials, shifting patient responsibility from the study site to the Study Champion. Traditionally, patient care was exclusively looked after by the sites; the new model will allow a more personal approach for patients, specifically more help getting through the trial.
Challenge
A specialty biopharmaceutical company targeting the plasma replacement for the treatment of hemophilia and immune deficiencies contracted with ARG to perform comprehensive CRO services for two different Phase III studies. Regulatory requirements included an audit mid-way through the process. The Sponsor faced difficulties both recruiting patients and then ensuring compliance.
Solution
Because of our relationships and experience in these immunological therapeutic areas, we able to not only meet recruitment targets but also ensure patient compliance. This was accomplished in several ways: use of specialized home health providers, daily interactions with the patients via our Study Champion, and a unique understanding of the patient experience in these disease states.
After successfully completing an audit of protocol design, conduct, monitoring, data management, and quality assurance processes, ARG won preferred provider status.
We have also found that providing this as an option has been a great recruitment tool for sites.
Moving Forward
Sponsors are realizing that there is no one-size-fits-all option for operationalizing clinical trials. The right partner is the right CRO for your trial, one that is patient-centric, has the relationships within the treater communities, and the technical know how to get the job done. Equal expertise is multiple functional areas clearly demonstrates team experience, commitment, and execution.
Your trial should enjoy high visibility in your CRO’s building, and ARG’s senior leadership are deeply involved in overseeing projects. Paul Bishop, CEO, founded ARG in 2004, maintains a close relationship with the Clinical Immunology Society (CIS) and American Academy of Asthma, Allergy & Immunology (AAAAI )and has been involved in Immunology development for over 20 years.
Immunology Specializations
ARG, with global reach, specializes in serving biotech and pharmaceutical companies in Phase I and Phase II drug development projects. We also understand that immunology clinical development projects often go hand-in-hand with rare disease, central nervous system and oncology indications.