ABOUT US
Access Clinical Research is a TURNKEY SOLUTION for your clinical trial patient recruitment. ACR coordinates all aspects of study trials, from ICH GCP training for the investigators and staff members, to contract negotiations and study management.
Our service includes investigator recruitment, patient enrolment, identification and retention, IRB correspondence, database management, site management and regulatory compliance. ACR provides GCP and protocol training for PIs and CRCs, and a wide range of study-related management and operational activities covering all aspects of clinical trials.
Our team of study-experienced professionals has the scientific capability and the management experience to conduct high-quality trials. With our patient database, our investigator network and clinical team have the medical expertise to work on specialty areas.
OUR MISSION
The mission of ACR is to facilitate patient recruitment with additional investigators for clinical studies, and site management in compliance with the highest industry standards, through a full range of regulatory and logistics support services.
ACR develops a network of additional sites and new investigators that are able to successfully enroll the right patient population in order to conduct these trials.
New to Clinical Research?
Interested in clinical research, but don’t know how to start? Unsure of the commitment it will take to become an investigator? Too busy to start by yourself? We provide training in regulations, site compliance with ICH GCP, ensuring the rights, well-being and confidentiality of subjects and data. We provide the support you need to become a successful clinical investigator.
For Experienced Investigators
Already conducting a clinical study and having difficulties recruiting patients? Join the ACR network to fulfill your requirements. Our network will help refer a new pool of patients for recruitment.
If you are interested in clinical studies, start by registering in our investigator network. If you are new to the field, training and site feasibility are available. You will be added to our network, making you eligible for clinical trials. ACR will find and present you with a study that matches your therapeutic interest and facilities.
Advantages of being an investigator
- Personal development by staying at the forefront of therapeutic research
- Professional recognition as a leader in the professional community
- Support & role in the evolution of medicine
- New potential treatments for your patients that can only be made available through participation in clinical trial
- New income stream
Join our investigator network.
To learn more about how ACR supports investigators and what it takes to be a clinical study investigator, contact us.
SMO Services
Site Selection Services
- Identification and recruitment of physicians and sites
- Performing study feasibility assessment of every sites
- Establishment of patient database to speed-up recruitment
Study Preparation
- Patient database to speed-up recruitment
- Study marketing and patient recruitment
- Patient identification and retention
Study Start-Up Activities
- Site initiation and on-going site management support
- Subjects recruitment, phone or web randomization
- Drug dispensing inventory and compliance follow-up
Documenting and Archiving
- Essential documents & Site Master File maintenance
- Site close-out and drug reconciliation & inventory
- Trial-related documents archival and maintenance
Study Conduct and Management
- Implementation of ICH GCP and Sponsor’s SOPs
- GCP training of physicians-investigators, if needed
- Follow-up on patient compliance & protocol adherence
Informed Consent Activities
- Informed consent document (ICD) design and obtaining informed consent
- Translation of ICD into vernacular languages
- Reverse translation and validation of informed consent form
Data Management
- CRF completion and data entry in EDC/CTMS
- Reporting AE/SAE to Sponsor or CRO and IRB/IEC
- Query resolution, audit preparation
Site Compliance Maintenance
- Alerting PI of potential protocol violations
- Alerting PI of potential ICH GCP violations
- Alerting Sponsor of potential misconduct
Investigators Site Services
Training ICH/GCP
- Implementation of ICH GCP and Sponsor’s SOPs
- GCP training of physicians-investigators, if needed
- Follow-up on patient compliance & protocol adherence
Sub-Investigator/Satellite Site
- CRF completion and data entry in CTMS, if requested
- Reporting AE/SAE to Sponsor or CRO and IRB/IEC
- Query resolution, audit preparation
Cybersecurity for healthcare companies
The problems faced by small, medium-sized and large corporate enterprises for the security of their information systems are numerous: protection of customer files, personal data, intellectual property, security of production systems… However, businesses now face new risks threatening their integrity, image and competitiveness: data theft, financial scams and sabotage of e-commerce sites.
Medical companies are not spared from these threats, especially small and medium-sized medical companies, as they may not have a team dedicated to the security of their information system.
The healthcare industry must integrate information security into the existing processes to be sustainable, efficient and to bring value to the businesses. Access Clinical Research has developed programs to fully understand the requirements of personal data protection, legal or regulatory laws and remain in compliance with the corporate customs and processes of the organization .
Preventing harmful incidents and computer attacks is often achieved through a simple integration of preventative measures, which contributes to the overall protection of the company. Below is a list of services offered for the cybersecurity of healthcare companies, to guarantee the security of their information systems.
Our services include:
- Raising awareness of good digital security practices and to support healthcare companies in the implementation of these security measures.
- Providing computer best practice guide and recommendation for non-specialists, based on the analysis of successful attacks and their causes.
- Verifying the security of existing infrastructure and adjusting/implementing protective strategies if needed
- Discovery and classification of vulnerable applications, assessment and management of vulnerabilities
Translation services
Translation of Clinical Trial Documentation
- Clinical trial protocols
- Case report forms (CRF) including e-CRF
- Informed consent forms (ICF)
- Investigators’ brochures (IB)
- Patient information leaflets (PIL)
- Patient questionnaires & diaries, including e-Diaries
- Patient-reported outcomes (PRO), including e-PRO
- Scales and QoL instruments
- Adverse events reports
Translation of Drug Registration Documentation
- Drug information (labels, inserts, packaging etc.)
- Standard operating procedures (SOP)
- Drug registration dossiers
- Regulatory applications
- Medical publications
Translation for Medical Device Manufacturers
- Operating and installation manuals
- Packaging inserts and labels
- Patents for medical and surgical devices
- Manufacturing process descriptions etc.
- GLP, GCP and GMP documentation
Languages
Arabic, Armenian, Bangladeshi, Belarussian, Bulgarian, Dutch, English, French, Greek, Hebrew, Kazakh, Latvian, Mandarin, Persian, Portuguese, Romanian, Russian, Spanish, Turkish, Ukrainian, Vietnamese.