Central Services

Central Services

From expert over-reading and bioanalytical services to training, medical writing and legal representatives services, CRO-Solutions® Central Services offers a tailored package of specialist services to fulfil our Client’s individual study-specific needs.

CRO-Solutions® personalised and targeted training supports all client needs whatever the requirement.  Unrivalled experience and an excellent working knowledge of the GCP, GCLP and GMP regulations, and the ability to create bespoke training solutions for individual needs ensures each staff member, at every level, understands and fulfils their study role compliantly and confidently.

Clear and pragmatic policies and procedures are an essential element of every Quality Management System. Adapted to your company’s needs and written by industry experts, the format, design and complexity of these records ensure a documented and concise step-by-step process which your staff can follow easily and compliantly.

Experienced in submissions to competent authorities and ethics committees, CRO-Solutions® can provide a full or part service support for studies, tailored to your needs. Our Project Management team have extensive experience of working with a select group of independent Research Ethics Committees who recognise the unique issues involved in respiratory trials. This, coupled with medic attendance at ethics meetings, enhances the approval success rate. Our experience is invaluable when drafting Participant Information Sheets, minimising issues often raised during ethical review.

CRO-Solutions® Project Managers regularly complete regulatory submissions and have an excellent understanding of the requirements that aid mitigation of delays and amendments and increase the likelihood of timely study start.

Our comprehensive, efficient and well-managed approval process ensures:

  • For Phase I studies: Submission to REC in the week prior to the meeting date and a response usually within 10 working days. Regulatory review usually within 14 days, or less, of submission.
  • For Phase II to IV Studies: Submission in the month prior to the meeting date and response usually within 10 working days. Regulatory review usually within 30 days, or less, of submission.

It is a governing requirement of sponsors that investigator sites are assessed as fit for purpose for regulatory and study requirements in order to ensure patient safety and data integrity.

At CRO-Solutions®, our proficient, experienced staff perform systemic, risk-based and objective examinations of trial-related documents and site facilities.  In combination with gap analysis and staff interviews, this ensures compliance with a range of regulatory requirements, as well as client confidence in patient wellbeing, safety and robust trial data.

Our efficient and thorough feasibility/audit report production and follow-up ensure that the site selected is evaluated in accordance with current regulatory requirements and client and study-specific needs; these investigations provide assurance that the final selection is the optimal choice.

In addition to our GCP expertise, our experience of GLP GCLP and GMP safeguards the compliance of study systems with facilities producing high quality, reliable study data.

Our pharmacy team are fully conversant with clinical trials requirements as they routinely conduct trials with our clinical site teams. With our knowledgeable and proficient staff (including Qualified Persons), we are able to offer a wide range of Pharmacy Services so your clinical trial requirements can be expertly handled. Our facilities include:

  • MIA IMP licence for primary and secondary packaging
  • Aseptically designed Pharmacy Assembly Suite GMP Grade C (ISO Class 7) equipped with a negative pressure Isolator GMP Grade A (ISO Class 5)
  • Restricted access study specific storage
  • 24 hour temperature control/monitoring for refrigerated, frozen and room temperature drug storage
  • QP Services including Auditing
  • Various IRT methods
  • Capsule filling
  • Over encapsulation
  • Liquid manufacture and dispensing
  • Robust accountability of IMP and NIMP
  • Production of unblinding envelopes for third parties, or use in-house
  • Destruction of IMP using an approved vendor
  • Batch certification of imported aseptically prepared sterile products, on-sterile products and gene therapy products

We have a dedicated bioanalytical team with over 10 years’ experience in all aspects of pharmacodynamic biomarker assay development and validation in a variety of complex matrices.

We have 3 bioanalytical laboratories dedicated to serum, sputum and BALF differential cell counts, plate based immunoassays (ELISA & Luminex), immunophenotypic and intracellular flow cytometry.

We are able to provide complete management of biomarker analysis within a clinical study, as a single site or acting in a central laboratory capacity, from study design including the generation of pre-clinical data to inform on biomarker suitability through to basic descriptive statistical analysis of the biomarker data generated.

In addition to assays currently validated at the MEU, our access to a variety of biological matrices allows us to offer a fully bespoke assay development and validation service dependent on specific study requirements.

Our experience in assay validation has led to the development of a robust fit-for-purpose assay validation approach, as published in the paper “Validation of Sputum Biomarker Immunoassays and Cytokine Expression Profiles in COPD” and presented at international respiratory conferences.

Currently validated assays include:

Inflammatory multiplex panels in serum and sputum including IL-1b, IL-1 receptor antagonist (RA), IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12p70, IL-13, IL-15, IL-17A, Eotaxin, Basic fibroblast growth factor (FGF), Granulocyte-colony stimulating factor (G-CSF), Granulocyte macrophage colony-stimulating factor (GM-CSF), Interferon (IFN)-γ, Interferon gamma[1]induced protein (IP)-10, Monocyte chemoattractant protein (MCP)-1, Macrophage inflammatory protein (MIP)-1α, MIP-1β, Platelet derived growth factor (PDGF)-BB, RANTES, TNF-α and Vascular endothelial growth factor (VEGF).
Inflammatory cell analysis via sputum, nasal and bronchoalveolar lavage (BALF) differential cell counts (DCCs) and flow cytometric analysis.
Intracellular Flow cytometric analysis of markers such as phospho-p38 and pSTAT5 in whole blood and sputum.

Development currently underway includes inflammatory multiplex analysis and intra-cellular flow cytometric analysis of BALF and Bronchoabsorption samples.

CRO-Solutions® is able to offer turn-around of full pharmacokinetic (PK) datasets, within 5 working days of sample receipt, for standard discovery bioanalysis.  In addition, we are able to provide assay development to determine the PK, toxicokinetics (TK) or in-vivo exposure of molecules, to suit your specific study requirements.  We are able to analyse your biological matrix to determine the drug concentration and where required, calculate the appropriate PK parameters

CRO-Solutions® delivers exceptional quality data for clinical trial via our respiratory function over-reading service. This includes:

  • Provision of specialist clinical trial equipment where required, allowing symmetry between clinical trial sites
  • Adaptive processes, facilitating the use of site’s own equipment where applicable
  • Onsite and remote clinical site training and support
  • Traceable review and amendment of endpoint data
  • Data management options available, to allow centralized storage and transfer of clinical trial data

As a center of exemplary training, CRO-Solutions® highly qualified physiologists have conducted training for large international clinical trials, ensuring precision, acceptability and compliance with international standards for lung function testing.  Qualified to national standards (ARTP) and fully compliant with current ATS/ERS guidelines, our physiologists determine acceptability for the following data sets:

  • Spirometry
  • Plethysmography
  • Gas Transfer (DLCO)

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.