Acceler8 Clinical Research conducts clinical trials and observational studies for pharmaceutical, biotechnology, and medical device companies. Our clinical trial development processes facilitate commercial efficiency and cost effectiveness in helping bring clients’ products to market. We are used to working with clients who have to be efficient with their resources. Our team are flexible in working in changing environments and are able to manage your clinical programme from concept, through to marketing application if required.
Our success is achieved through recruitment and development of high calibre staff. Customer loyalty is also an important factor in our success. All of our sponsors have awarded us repeat business and/or recommended us to other organisations.
Acceler8 Clinical Research has a wide range of therapeutic area expertise and all of our personnel have direct, hands on experience of Clinical Trials and ICH GCP with the ability to provide a real world insight into the role.
- Project needs assessment and contingency planning
- Overall project planning and communication planning
- Resource allocation and team management
- Risk assessment, tracking and management
- Budget development and tracking
- Management of project timelines, teams and deliverables
Clinical Trial documentation preparation
Design/review/translation of:
- Protocol
- Investigator Brochure
- Master Informed Consent Form
- CRF
- Pharmacy Manual
- Operations Manual
- Clinical Monitoring Plan
- TMF set up and management
Clinical Monitoring and Site Management
- Feasibility
- Site identification and qualification
- Investigator Site set up and initiation
- Recruitment planning and tracking
- IMP Management
- Routine Monitoring visits
- Site Management
- Motivational visits
- Site audits
- Resolutions ad responses to queries
- Site close out visits
- eCRF design and association documents
- User Acceptance Testing
- Data Management Plan
- eCRF Completion Guidelines
- CRF tracking
- Mid study changes / protocol amendment
- Data entry / editing / verification
- Discrepancy management
- Medical coding
- SAE reconciliation
- Third-party vendor data management
- Database lock
- SAP development
- Programme listings, figures, tables
- Final analysis & Statistical report
- Development and maintenance of database
- Preparation of case narratives
- Expedited SUSAR reporting
- Query resolution to case closure
- Medical Coding
- Development of DSUR
- Protocol and CSR
- Manuscripts and poster publications
- Publication strategy
- Regulatory Submissions
- Ethics Submissions
- CSR preparation
- Manuscripts preparation for publication
- Medical Monitoring 24/7 cover
- Medical assessment of subject eligibility
- Medical review of data listings
- Therapeutic area training
- Protocol and project-specific safety training at investigators meetings
- Natural history of disease studies
- Rare disease registries
- Phase 4 studies
Other
- Pre-Clinical Development
- Clinical Trial Packaging
- Central Lab Management
- Contract Preparation and negotiation