Full Service à Azelix focuses on providing the right solution for your need. With our full service offerings, we can tailor our solutions to your requirements. Our team of experts will flexibly collaborate with you to make the most positive impact possible
Project Managementà Azelix understands that having a committed project team led by an experienced Project Manager (PM) is integral to the success of your clinical development. Our PMs have at least 10 years of industry experience and are supported by project teams that are fully trained to understand the nuances of clinical study management.As the primary point of contact, it is a top priority for our PMs to provide timely and transparent communication with a solutions-oriented mindset. Our PMs not only provide operational expertise, but are also proactive and therapeutically aligned with your project needs and act as an extension of your internal project team. We strive to provide nothing less of “best-in-class” project management services to ensure the success of your clinical study.
Our project managers will:
- Serve in a leadership role and create synergies amongst all project team members and partners to ensure seamless project execution.
- Manage study milestones/activities, budgets, and timelines in accordance with the contract.
- Take initiative to mitigate projects risks ensuring the highest quality results and data.
- Maintain an open and collaborative mindset so that we can help bring your therapy to the market faster.
At Azelix, we ensure that you have full confidence in your assigned PM by involving them during the earliest planning stages of your project starting from the development of RFP responses.
- Regulatory Affairs
- Scientific & Strategic Consultation
- Medical Writing à Azelix’s Medical Writing Team ensures project timeline adherence by being highly responsive and committed.
The success of a clinical development program depends on the proper documentation of research plans and results. Azelix offers a range of flexible solutions to support various clinical study documentation needs.
The medical writing team averages 25 years of experience, and many are Ph.D. Combined experience exceeds 150 years as a team.
Our team of medical writers have experience working with a broad range of indications and therapeutic areas. We focus on offering flexible solutions to meet your needs in different stages of product development. We can assist you in the development, preparation, and review o and publishing documents in support of regulatory submissions and clinical trials, including
- Study protocols
- Informed Consent Documents
- Clinical Study Reports (CSRs)
- Case Report Forms (CRFs)
- CRF Manuals
- Study Reference Manuals
- Patient Diaries
- Clinical Trial Registry Documents
- Safety Narratives
- Clinical Evaluation Reports (CERs)
- Investigator’s Brochures (IBs)
- Investigational New Drug (IND) Applications
- IND Annual Reports
- New Drug Applications (NDAs)
- Drug Master Files (DMFs)
- eCTDs: Module 2 (2.2, 2.4, 2.5, 2.6, 2.7) and Module 5 (ISS, ISE)
- 505(b)(2) Searches and Summaries
- Marketing Applications
- Orphan Drug Applications
- Drug Establishment Registration
- Standard Operating Procedures (SOPs)
- Meeting Reports
- Manuscripts for Publication
All documents undergo an internal review to ensure consistency and quality.
- Site Relations
- Clinical Monitoring à Quality of clinical monitoring has a tremendous impact on overall timelines and study quality. We strive to achieve the highest data quality possible for your trial by assigning only experienced, therapeutically-aligned CRAs in the field.Our CRAs are expected to have:
- Demonstrated high-monitoring proficiency prior to being assigned to a study
- Strong therapeutic experience in the disease of indication
- Gone through rigorous general and study-specific training
Our CRAs have conducted monitoring visits for:
- Data collection oversight
- Source Data Verification (SDV) against CRFs
- Regulatory compliance
- Speedy data query resolution
- Recruitment boosting and area-of-improvement identification
Our monitoring team has both traditional, remote, and risk-based monitoring experience. With your objectives in mind, we will propose the best approach to meet your study’s needs. In general, clinical monitoring covers:
- Pre-study Activities
- Site Initiation
- Interim monitoring
We employ central monitoring tools and strategies to ensure that we’re identifying data trends, and addressing emerging issues as soon as possible.
- Data Management
- Biostatistics & Programming
- Medical Monitoring