AAI offers a full-service clinical unit dedicated to oncology drug development and clinical trial management. Our center of oncology operations is located in Paris, France with clinical operations in North America, Western, Central and Eastern Europe, and South America.
We have a significant depth of global oncology experience, performing early product development (notably first-in-man) via MTD definition, PK analysis and recommendation of Phase II/III strategies. We also have solid experience in managing large global pivotal Phase III studies.
Oncology's expertise resides in our:
- Targeted product development and effective registration strategies
- Preclinical and clinical optimization of single agent and combination therapies, notably for first-in-man molecules
- Exploration of treatments for targeted populations with unmet needs
- Implementation of the trials necessary to achieve successful registration
We believe Oncology's strength as a clinical research unit lies in our highly medicalized approach to drug development. Our medical oncologists are involved at every step of the process, from the clincial study design and throughout the study, ensuring the medical integrity and interpretation of the study data. We are committed to performing stringent quality GCP operations with optimal timelines. Together these elements ensure that Oncology's intervention results in pertinent and well-executed trials with expedited approval for marketing and rapid adoption of new cancer treatments.
We offer:
Oncology consulting services
Our team is composed of senior in-house oncologists. Independent consultants specialized in US and European oncology regulatory submissions, preclinical and PK research reinforce the consulting team to provide:
- Lead assessment
- Regulatory-driven preclinical and clinical development plans
- Analysis of stalled programs and identification of therapeutic niches
- Registration, product launch and post-marketing
A wide range of experience with
- Almost all solid tumors and several hematological diseases
- A variety of cancer therapies (cytotoxics, cytostatics, monoclonal antibodies, vaccines, hormonal therapies, etc.)
Access to a global network of experienced investigators
One of our unique features is our first-hand knowledge of the capabilities, performance level and patient accrual rates at a large number of sites around the world.
- A worldwide network developed through our global presence
- Studies and medical reviews performed in over 500 sites worldwide
Unique study design by our medical oncologists
Our medical division includes several medical and regulatory oncology consultants. In-house oncologists are based in France, USA, Argentina, and Croatia.
- Medical/scientific input ensures study feasibility
- Real-time data evaluation in Phase I studies optimizes dose/schedule, maximizing patient safety
- Realistic Phase II-III study design (eligibility criteria, endpoints, controls, etc.)
Clinical operations expertise
We can manage either all aspects or specific activities of a clinical trial, according to the Sponsor's needs. Over 60% of our personnel have higher degrees and our staff turnover rate is very low.
- Rigorous project management by experienced staff ensures timely and seamless study implementation
- Quality clinical monitoring with oncology-specific training, GCP/ICH compliance, up-to-date in the field, multilingual; our monitors are responsible for the quality of their data from A to Z
- Medically-driven data management (MedDRA, WHO-DRUG, NCI-CTCAE, etc.) and statistical analyses, using validated systems (SAS®/SPSS®/Oracle Clinical® - FDA 21 CFR Part 11)
- Medical writing: ICH-compliant protocols, clinical study reports, peer reviewed publications (preclinical and clinical), IBs, IMPDs, abstracts, posters, clinical overviews and summaries
- Pharmacovigilance: 24/7/365 SAE reporting, narratives, Health Authority reporting, Oracle AERS
- Regulatory Affairs: local ethics, national health agencies, regulatory submissions, FDA/EMEA interactions
- Quality Assurance: global SOPs, regular study audits
- On-site medical source review by oncologists
- Database cleaning for registration trials
- Drug supply and distribution
- Training in oncology tailored to the Sponsor's needs
