A-Pharma CRO has more than 20 years of experiences in the field of clinical trials (Drugs,dietary supplements, medical devices, etc.) mainly in the Czech and Slovak Republic
You can rely on our Project managers, who will accompany your project from start to finish, taking care of all issues arising throughout the project. They are highly qualificated MD and PhD experienced in supervising and managing the team to ensure smooth start, conduct and closure of the project.
Our regular team training ensures that new regulations and guidelines will be promptly taken on board. Project managers provide complex guidance and support to Clinical monitors and perform ongoing quality control steps. The whole team is systematically instructed to forward verified and accurate data on time.
Quick feasibilities in different areas
Flexibility and diligent A-Pharma CRO team as well as large database of clinical physicians, head physicians of hospital departments, top specialist in various areas and also great previous cooperation with them, enable us to gain fast feasibility results for you so you can benefit from early decision – making.
Quickly investigators identification from large databases
A-Pharma large database of clinical physicians and related references guarantees selection of the most appropriate investigational sites. Our training of the investigators ensures high quality performing of Clinical trials according to GCP.
A -Pharma medical writers are familiar with all pharmaceutical regulatory documents as well as informed about critical issues that may arrise. Their professional approach combines scientific insight, language skills, writing techniques and medical regulatory knowledge while creating:
- Clinical study protocols
- Standard operation procedures
- Manuals and templates for document standard
- Clinical study report
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
- Statistical analysis plans
- Statistical presentations for regulatory authorities
Regulatory affairs including submissions to the State Institute for Drug Control and to local and central Ethics committees
A-Pharma expert team assures parallel submissions to regulatory authorities, Local and Multicentric ethics committees, and institutional review boards (State Institute for Drug Control) including further communication and maintenance related correspondence.
We have accomplished more than 50 successful submissions.
There is nothing more important to a clinical trial’s success than recruiting, contracting, and equipping sites and investigators for enrollment success. We understand the needs, challenges and dynamics of effective sites recruitment. A -Pharma CRA’s consider the impact of the following factors to blend an effective sites recruitment strategy.
Our goal is to find for you the right sites, at the right time, to support delivery of effective study results.
We help you to arrange Hospital contract, Investigator contract, and Laboratory or Pharmacy agreements according to national law and requirements in highly professional way using excellent negotiation skills. The result is to provide you with the most appropriate and cost – effective solution.
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 is conversant with English so that we are able to cover non-certified translations of pharmaceutical or medical documents.
Study drug distribution
As A–Pharma possess license for drug distribution, we are ready to operate distribution of study drug and other study material for you.
A-Pharma has a team of qualified and well-trained Clinical monitors with excellent reporting and communication skills. They are subject to a well – defined selection process considering their personal qualities and carrier background. Qualities such as reliability, accuracy and motivation are highly emphasized in our whole team. Members of monitoring team are mostly graduates in the natural sciences, pharmaceutics or medical doctors. However, they undergo regular training in order to ensure perfect monitoring of Clinical Trials in accordance with:
- principles GCP
- country specific law and requirements
- international guidelines
- study –specific requests (Protocol, SOP etc.)
In addition to performing on site visits (pre-study visits, initiation visits, monitoring,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 data verification, adverse event reporting
- controlling adherence to protocol, SOP and other regulations
- properly reporting sites status and issues to the sponsor
- presentations at Investigator meetings
The objectives of a pre-study visit are to review the adequacy of the site, the training and experience of the study staff, the access to the right patient population, and the site’s interest in the study.
During the initiation visit our monitors spend a great deal of time training or reviewing the study protocol, study design and answering questions from the site personnel. They discuss the Investigator’s Responsibilities as related to the regulations to ensure there is agreement and understanding.
Close out visits
Study close out visit is a final visit conducted after all subjects have completed the study and all data are recorded in case report forms (CRFs). The purposes of the visit are:
- to ensure that all investigational drug have been administered according to the protocol
- to ensure that all documents regarding investigational product accountability are accurate, complete, and legible
- to complete monitoring at the study site and return all completed CRFs to the Sponzor
- to confirm the return (or final disposition) of all study-related material
- to ensure that all regulatory documents are on file at the investigational site
- to review with the Investigator his/her responsibilities after termination activities have been completed
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.
We are able to completely cover the whole course of the project including Final clinical report. A-Pharma medical writers will ensure consistency across document as well as compliance with GCP, pharmaceutical and regulatory requirements. 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.