CRO Services

Our CRO Services

CRO-Solutions® is proud to offer its clients a single solution for their clinical trial programmes.

A single contract with CRO-Solutions® bridges the gap for clients looking for the leading providers of clinical trial services in a diverse and complex field. CRO-Solutions® provides a bespoke offering of their own highly accomplished and experienced staff and prominent, respected companies to deliver a solution tailored to the individual resource requirements of the client.

Tailoring bespoke trial designs into fit-for-purpose data management processes, CRO-Solutions® will ensure the highest level of data quality is achieved.  Working with a proven data management team that specialize in early phase trials and utilising some of the most recognised eDC platforms (including Syne-clin, Medrio, iMedidata, Oracle InForm, Veeva Vault, Trialmaster and many more), you can be assured that CRO-Solutions® has the experience and technology to produce dependable, secure and regulatory compliant data in a timely manner. Harnessing the quality infrastructure synonymous with the CRO-Solutions® brand, your data management requirements will be built, curated and delivered with the highest quality standards.

With the requirement for all clinical trial Sponsors to appoint a medical monitor, CRO-Solutions® has positioned itself to ensure these regulatory obligations are met with the provision of proficient and practiced medical experts to oversee the entire clinical trial activity.

The expert medics act as a point of reference for both the investigative site and wider study team members and can include the following services:

  • Review of the study protocol, Investigator’s Brochure, SAE Management Plan
  • Review and resolution of subject eligibility issues during recruitment
  • AE/SAE CIOMS/Narrative Review and sign-off in accordance with the SAE

Our erudite staff have experience in an array of therapeutic areas enabling them to produce clear, succinct and compliant trial documentation.

We have the ability to produce and develop detailed and comprehensive:

  • Clinical Trial Protocols
  • Safety Reports
  • White papers
  • Clinical Study Reports

Working in tandem with our on-site medical experts, CRO-Solutions® medical
writers work to ensure our clients’ required timeframes and study needs are consistently met.

CRO-Solutions® monitors work in close collaboration with our clients, to provide on and off-site monitoring services to ensure a first-class review of clinical trial data in accordance with client, or CRO-Solutions® SOPs.  Whilst maintaining their independence from the MEU team, our monitors are fully familiar with the MEU systems and processes, enabling them to offer an efficient and thorough review of data.

Our monitors, provide blinded and unblinded monitoring services to sites worldwide.  Irrespective of the site location, they follow a systematic, risk-based approach to deliver exceptional quality data.

CRO-Solutions® is perfectly positioned to offer pharmacovigilance services which provide a robust compliance programme for safety monitoring whilst maintaining the flexibility required for the changing nature of development programmes.  With established agreements in place, we work with a leading provider who ensures compliance from the smallest Phase I study, through to complex multi-centre and global clinical trials.

The following services are available to meet the needs of our clients:

  • Drug Safety Project Management
  • Collection and follow-up of Serious Adverse Events (SAEs) from clinical trials
  • Electronic management of SAEs on the ARISg™ database
  • Expedited & routine reporting to Competent Authorities, Ethics Committees and investigator sites
  • Responsible Person for Eudravigilance set-up, oversight & management
  • Reconciliation with clinical database, compliance review and oversight
  • 24 hour cover

With a successful proven track record of managing sites across Europe, our knowledgeable and highly experienced
CRO-Solutions® project managers have strong interpersonal skills enabling coordination of all clinical trial activities and effective liaison with stakeholders.  With diverse therapeutic experience, they are conversant with the complexities of trial management and mitigation and resolution of a range of issues.  We pride ourselves on maintaining the same project managers from s

tart to end of clinical trials, providing a consistent point of contact for our clients.

Our proficient clinical  pharmacologists have extensive experience in all aspects of protocol design, clinical
pharmacology, safety, pharmacovigilance, and patient recruitment strategies, enhancing the success of our client’s clinical trial outcomes.  

With CRO-Solutions® headquarters based on a “centre of clinical excellence” hospital site, we have access to specialist clinicians and Key Opinion Leaders across the region. These experts understand the scientific complexity and study endpoints in relation to recruitment and protocol development. They translate their pharmacological understanding of the Investigational Medicinal Product into a practical, effective protocol incorporating the appropriate patient population. 

pharmacology, safety, pharmacovigilance, and patient recruitment strategies, enhancing the success of our client’s clinical trial outcomes.  

With CRO-Solutions® headquarters based on a “centre of clinical excellence” hospital site, we have access to specialist clinicians and Key Opinion Leaders across the region. These experts understand the scientific complexity and study endpoints in relation to recruitment and protocol development. They translate their pharmacological understanding of the Investigational Medicinal Product into a practical, effective protocol incorporating the appropriate patient population. 

CRO-Solutions® understand that the statistical fitness of client study design is required to meet all the clinical objectives. Working with a team of statisticians, consultants and SAS programmers, CRO-Solutions® are able to support our clients with development planning strategies, advising on the most appropriate study design and implementing an accurate Statistical Analysis Plan to ensure successful evaluation and reporting activities. The team will convert the plan into reality from

quality programming of datasets though to outputs and reports.

The statistical services offered include:

  • Development planning, study design and expert statistician consultancy
  • Sample size, statistical analysis, methodologies for avoiding bias etc.
  • Randomisation
  • Statistical Analysis Plan (SAP)
  • Detailed description of all statistical analyses and data summaries
  • Shell Tables, Figures and Listings (TFLs) based on internal or client standards
  • CDISC SDTM and ADaM datasets and associated documentation (define.xml, reviewer’s guides and SDTM annotated CRF)
  • DSMB delivery
  • Interim analysis
  • Regulatory authority interactions and meetings

With the regulatory requirements for maintenance of essential trial documentation requiring significant time, attention to detail and resource, CRO-Solutions® are proficient at supporting their clients with provision of Trial Master File (TMF) set-up, management and ongoing maintenance services. Acting as a hub for all trial stakeholders, our staff liaise with each relevant party to gather, maintain and file all requisite documents and preserve inspection-readiness of the records. CRO-Solutions® project managers work in tandem with our Clinical Research Associates to uphold the ongoing health of client’s TMFs, in accordance with their needs, CRO-Solutions SOPs and the regulatory requirements.

Interested in a proposal? Have a question? We’re happy to answer. Just fill out the form below, and we’ll get in touch with you as soon as possible.