Medical devices include a wide range of products varying in complexity and application.
Medical device is defined as any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination. There is growing need to use various medical devices in following areas:
- Diagnosis, prevention, monitoring, treatment or alleviation of disease
- Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap
- Investigation, replacement or modification of the anatomy or of a physiological process
- Control of conception
A growing number of new medical devices go through the increasingly complex process of clinical trials and regulatory procedures that lead to market. All the related processes are very similar like the procedures with medicaments. However, there may arrise slight particularities or other difficulties than in a typical clinical trial.
Whole A-Pharma team is familiar with all steps needed for clinical trials of medical devices.
The same way as in medicines clinical trials we take care of following activities:
Medical writing
A-Pharma medical writers have a thorough knowledge and experience in writing documents essential for clinical studies. They create well-structured documents that effectively and clearly describe research results, and present other information clearly and concisely. The medical writers also make sure the documents comply with regulatory or other guidelines in terms of content, format and structure.
We deal with writing following documents:
- Clinical study protocols
- Informed consent forms
- Case report forms
- Questionnaires
- Standard operating procedures
- Clinical study reports
Statistical plan
Our business is to support your product development with the right, accurate and reliable information. A–Pharma experienced statisticians use their best knowledge to provide you with following services:
- Statistical consulting
- Trial design
- Sample size estimation
- Randomization
- Statistical analysis plans
- Statistical presentations for regulatory authorities
Regulatory affairs including submissions to the Ministry of Health and to local Ethics committees
A-Pharma expert team is experienced in integrated planning, management, preparation of dossiers and submission to regulatory authorities for smooth transition and conduct of clinical research. We can quickly identify potential regulatory requirements to meet the local regulatory challenges particularly requirements of local Ethics committees and Ministry of Health.
Sites recruitment
The most essential process is to find the appropriate research centres as well as motivated Investigators who are easy to co-operate in responsible way.
A-Pharma understand the needs, challenges and dynamics of effective sites recruitment to ensure smooth start-up of your project.
Our goal is to find you the right sites, at the right time, to support delivery of effective study results.
Contract negotiation
The clinical trial negotiations typically include the companies whose medical devices are being used in the trial, the academic medical centres where the trials are to be conducted, and the principal investigators who lead the trials. A–Pharma has successfully arranged a number of Hospital or Investigators contracts.
Our business is to provide you with the most appropriate and cost – effective solution.
Professional certified translations
Since all essential documents must be available in English, we cooperate with several translating agencies that are able to provide us with certified pharmaceutical or medical translations within a few days. Moreover, A-Pharma team members have degrees in the sciences and use current medical terminology, appropriate medical terms and culturally sensitive language in order to reflect the intended meaning of a medical text.
Study devices distribution
We are ready to operate distribution of study devices and other study material for you.
Monitoring:
Trials must be monitored for recruitment progress, quality of data, and adherence to GCP, to patient care or prevention standards, and early evidence of benefit or harm. Frequency of monitoring visits is set in the study Protocol, however, there are always pre-study visits, initiation visits, routine monitoring visits, and close out visits.
A -Pharma has a team of qualified and well-trained Clinical monitors with excellent reporting and communication skills. They are instructed to intensively co-operate with Project managers to forward accurate data or issues from sites on time.
In addition to performing on site visits (pre-study visits, initiation visits, routine monitoring visits, and close out visits), A -Pharma Clinical monitors are responsible for:
- reviewing specific documents and translation
- ethics committee and regulatory authority submissions
- updating and maintenance of Investigator Site Files and shadow files
- monitoring subjects recruitment, source documentation, adverse event reporting
- controlling adherence to protocol, SOP and other regulations
- properly reporting sites status and issues to the sponsor
- presentations at Investigator meetings
Query resolution
We have specific tracking system for queries, each database entry is verified, discrepancies are solved by queries issuing by Data Manager and solved by Medical advisor or investigator. Each query is documented, tracked and entered into database.
Clinical report
The Clinical Report provides an opportunity to reflect on the clinical work of the site. A -Pharma team of consultants and scientific writers are adapted at compiling and communicating the study results in a clean and efficient manner suitable for submission to regulatory agencies. Appendices to clinical study reports consist of the largest component of many regulatory submission dossiers and require very precise professional approach. We ensure that GCP principles and ICH compliance will be carefully observed.
