Clinical Trials (Phase I to IV)

SSS International Clinical Research provides cost-effective, high quality, comprehensive, and internationally integrated services to develop and commercialize the products of our clients throughout Europe in the pharmaceutical, biotechnology and medical device industries.


SSS International Clinical Research also offers customized services, tailored to your exact needs. We are always glad to supply our clients customized solutions. So please contact us to discuss your Needs.

 

Our main Clinical Trial Services include:

 

Startup Services

We assist sponsors in getting trials up and running as quickly and efficiently as possible. Our services include:

Site selection and feasibility: SSS achieves study timelines by providing our clients with accurate projections and experienced investigators, with accelerated patient recruitment and high quality data. This is possible due to our local experience that allows us to identify qualified investigators based on previous clinical trial expertise .

Regulatory document collection: our solution assures the efficient distribution, collaborative compilation and review/approval of site level regulatory documents. Using SIS, our site start-up process assures delay free site onboarding.

Contract management: We can provide contract template, or we can translate your contract. SSS can be envolved in contract negociation or obtaining legal advice and finally, the appropriate signature.  Obtaining necessaary contracts signatures in a short period of time means submission process will start without delay.

Submissions to authorities: avoiding any delays during regulatory submission process and obtaining approvals from EC’s and Regulatory Authorities, are key factors for a clinical study to be initiated in a timely manner, therefore our employees have knowledge of envolved processes and local requirements, processes that SSS has refined in more than 20 years of experience in clinical trials.

Translation: SSS can translate contracts, ICF, questionaires and diaries, etc.

Project Management

Our company’s primary goal is to complete every project on time and on budget while maintaining high quality services.

 

Our project managers (PM) accomplish their goals due to:

Experience: our employees have developed a set of skills particularly needed for this job, like good communication, leadership, critical thinking, coaching, integrity, accountability, oversight.

Planification: our PM’s carry out planning for the whole project as well as detailed planning for each phase, based on an analysis of relevant information. They ensure that the right people, resources, methodologies, and supporting tools are in place for each project phase, so that we can deliver on quality standards, on time and in budget.

Organization: effective organisation is crucial to the success of each project, so we will assemble and direct appropriate teams for the project, assign authority and tasks and mediate between the parties involved in the project

Tools: SSS’s team is using our own Clinical Trial Management System (CTMS) tool named Study Information System (SIS) for tracking progress at site and trial level, oversight of involved processes, improving productivity and effectiveness, document and escalate issues.

Methods: by using PDCA (Plan-Do-Check-Act) cycle we are always in control of involved processes.


Due to our project managers skills, we will achieve compliance with regulatory requirements, and therefore optimize managing project deliverables. They will ensure that all aspects of the project are planned, implemented and controlled, achieving the objectives in respect of quality, time and cost of the result.

Monitoring

Our CRA teams deliver faster, more efficient monitoring in terms of quality and costs. Due to our comprehensive training and development program, our monitors offer better investigator site support and data oversight. SSS CRA’s training program ensures compliance with local law and EU legislation. For additional coaching and quality assurance, we perform accompanied site and co-monitoring visits, that ensures our routine monitoring visits are performed and reported according to defined procedures whilst identifying early potential issues and supporting our CRA’s with their professional development. 

SSS CRA’s are committed to perform all types of visits, from site evaluation to site close-out visit,  to the highest standards and are dedicated to deliver high quality results. They have experi-ence across multiple therapeutic areas and are highly educated and experienced professionals with relevant background. Effective monitoring in terms of quality and costs is possible due to a combination of onsite and remote monitoring and mix of these components is being made in ac-cording with risk based/ adaptive monitoring principles and risk analysis.

During the on-site visits our CRA’s document that correct procedures are being followed and that scientific and ethical conduct of the study is uncompromised, identify potential problem areas, design approaches to prevent problem development, and suggest methods to increase the efficacy of site staff in performing the duties related to the study. We provide our CRA’s with advanced monitoring tool integrated in our CTMS (SIS) that deliver real time data at trial and site level regarding recruitment , regulatory documents status, green light process, amendment, implementation and outstanding issues. All these and the administrative reports provided by SIS, keep project teams apprised of the status and progress of the clinical trial.

Medical Writing

Our employees have  medical, pharmaceutical backgrounds and are experienced in producing high quality documentation. They work to integrate the medical and statistical results of your clinical trial into a document that meets the needs of the client and the regulatory requirements. Our medical writers work closely with Clinical Data Management and the Regulatory Affairs teams to provide high quality compliant documentation in an efficient and timely manner.

The company’s specialists are working in accordance with local and international standards,  EMA, FDA , GCP requirements and the company’s SOPs.
 

Our Medical Writing services include, but are not limited to:

Generation of Clinical Study Protocols

Writing on Clinical Study Reports

Patient Narratives

Investigator Brochures

Patient Information and Informed Consent Forms

Summary of Product Characteristics

Medical Communications

Manuscripts, Abstracts and Posters 

Data Management/Statistics

SSS International Clinical Research statistics division can provide clients with data abstraction, data review and coding, (double) data entry, database verification and database editing, and problem data resolution.

Data Management
SSS International Clinical Research will design database systems according to the client's specific needs so that data can be entered effectively. Prior to data entry experienced employees will screen data for errors, omissions and other deficiencies (medical review). Queries concerning the data are generated manually during the medical review on the one hand and automatically by the system after data entry on the other hand. SSS International Clinical Research is experienced concerning the interaction of electronic data entry systems (EDC) with relevant monitoring procedures.

Statistics
Master's level biostatisticians provide clients with assistance in all phases of drug development. Our biostatisticians evaluate data to assure that sound scientific analyses using current analytical techniques can be performed according to accepted biometric standards. We routinely uses SAS for all statistical analyses and data listings.