Phase I-III clinical development solutions
Fully integrated clinical development solutions for Phase I-III clinical studies. We deliver the full range of clinical development services you would expect from a huge CRO. With a structure and company size that gives you the personalised, tailor-made and responsive approach you’re looking for. We maintain quality delivery underpinned with industry-leading systems providing visibility, control and inspection readiness including Veeva eTMF, Veeva CTMS and Oracle InForm.
Our experienced project managers collaborate closely with the entire study team, driving activity to keep your study on track. It’s important to have a tight-knit team. Our project managers use Veeva CTMS to streamline study management so that informed decisions on your study can be made faster with greater oversight and efficiencies. Responsive and forward-thinking our project managers will work as your ally to keep your project on track, within budget and mitigate risks.
We deliver a full range of Regulatory Affairs services for the global pharmaceutical industry across the complete product life cycle. We invest in the Cortellis Regulatory Intelligence database to support your regulatory affairs.
We have built a robust regulatory strategy aiding fast study approvals and setup. An experienced team that can facilitate rapid contact with Regulatory Health Authorities, Ethics Committees and Notified Bodies during the development and maintenance phase of clinical trials and clinical investigations. With established relationships with the Regulatory agencies, we are ideally placed to support with preparation, conduct and reaching client objectives of face to face meetings with the Regulatory Health Authorities for scientific advice / protocol assistance.
- Clinical Trial applications in more than 30 territories
- First in Man and Phase I-III Patient studies with complex biological products & radiopharmaceuticals
- Voluntary Harmonisation Procedure (VHP) submissions
- Medical Device Clinical Investigations
- Drug-Device combination studies
- Certified translations and back-translation of clinical trial application documentation into multiple languages
- Marketing Authorisation Applications
- Strategic Regulatory planning
- Due diligence / Gap analysis on Regulatory documentation
- Technical advice on Chemistry Manufacturing Control (CMC),
- Preparation and Conduct of face-to face meetings with regulatory authorities
- Paediatric Investigational Plans
- Orphan Drug Designation
Consulting & strategic support
Let our experts work as an extension of your team, providing strategic support to maximise the value of each clinical study to your overall development programme. Support includes regulatory strategy, GAP analysis, orphan drug designation (ODD), clinical study design, full management of scientific advice meetings with the EMA, FDA & MHRA and developing clinical advisory boards.
Our CRAs are decentralised, meaning that they are located close to clinical sites, enabling them to facilitate close communication which drives patient enrolment and site management. We enable our CRAs to perform professionally with the outmost regard for patient safety by providing gold standard systems for them to ensure a single source of truth. Veeva eTMF and CTMS are the systems that we use to confirm this. Our CRAs use Oracle InForm to access and review patients’ data across sites, reducing study timelines.
Effective and efficient set up, analysis and reporting is crucial ensuring your central laboratory requirements are executed and maintained. Communication is a key factor so you will have a dedicated project manager assigned who supports trial implementation and acts as a single point of contact for continuity
Consistent and high-quality delivery of sample supplies and logistics are managed by a dedicated customer service team who focus on:
Adaptability Distribution of supplies -right time right place, often to sites where SIV are at short notice. Amendments to documentation or LIMS are quickly and easily accommodated. Supplies are dispatched within one week of receipt of request.
Collaboration Experience of inter laboratory collaboration where the supplies design will be shared and fully agreed by all laboratories utilising shared expertise.
Strategy Experience gained is utilised when composing sample handling manuals for ease of use by operators. Supplies structured for ease of use at each site allowing sites flexibility, preventing wastage and reducing costs. Sample shipments set up with electronic tracking and, where required, temperature monitoring loggers.
Sustainability Supplies provided to sites and their expiries are fully tracked. Sites will be automatically re-supplied prior to any material expiry. We provide a comprehensive analysis service and are committed to ensuring the prompt analysis and electronic transfer of results, helping you make critical decisions in a timely manner.
We work with a network of partners/providers to deliver requirements involving specialised techniques, removing the necessity for the you to manage multiple laboratories.
GMP and GCP compliant IMP Management, offering manufacture, global distribution, importation and pharmacy services, delivered by experienced team including in-house QP and pharmacists.
Licenced by MHRA to manufacture and package sterile and non-sterile products, including solutions, capsules, infusions and injections, radiopharmaceuticals. Manufacturing and QP certification carried out on-site at the Clinical Pharmacology Unit, allowing rapid turnaround times. Other services provided include IMPD writing and review, and licenced Controlled Drug handling.
Our highly qualified and experience Pharmacovigilance team can provide:
- Safety database hosting on Aris Global, a system that is 21 CRF part 11 and E2B R3 compliant. The system allows the accurate processing of cases for signal detection, aggregate report generation, and statutory electronic reporting to regulatory authorities
- Safety data migration
- Standard Operating Procedures (SOPs)
- Auditing services
- European Economic Area (EEA) Qualified Persons for Pharmacovigilance (QPPV)
- EudraVigilance Substance, Product, Organisation and Referential (SPOR) User registration and Responsible Person (RP)
- Aggregate report writing (Development Safety Update Report (DSUR), Periodic Safety Update Report (PSUR))
- Clinical trial and post-marketing case processing
- Regulatory reporting
- Development of Risk Management Plans (RMPs)
- Signalling detection, evaluation and validation
- Literature search and review
- Development of the pharmacovigilance system master file (PSMF)
- Safety Data Exchange Agreements (SDEA)
Biometrics (DM & Stats)
We provide fully validated FDA and EMA compliant electronic data management systems. Oracle Inform which is amongst the preferred solutions used by global biotech and pharmaceutical industry as an eCRF system is just one of our solutions, we have experience in other eDC platforms and as requested by you we can undertake work in other eDC systems if that is your preferred option.
Our data management team can provide you with:
- CRF design and development of the eCRF database
- eCRF database set up – including integration from third sources including central laboratory, central ECG, ePRO
- Continuous data management and data cleansing – electronic and manual checks on the data to detect inconsistencies
- Medical monitoring and review – identify protocol deviations ensure consistency with endpoints and ensure that adverse events are well recorded and followed up
- Medical coding Medical review is supported by built-in eCRF reports and targeted data listings generated and validated by Simbec-Orion group programmers
- SAE reconciliation – guided by a SAE reconciliation plan events are captured in the database
- STDM/CDISC SDTM conversion – or other CDISC standard related – services. For SDTM conversion internally developed generic support tools are used to support SDMT conversion sub-tasks. This allows for having very lightweight SDTM domain-specific programs (rapid development, easy review, seamless transfer of tasks between developers), and helps in maintaining high overall quality and data accuracy
- Data integration – we can pool or merge databases, data migration between database schemes, verifying data integrity
- Data analysis Biostatistics and Statistical programming – full statistical support to customers from elaborating study design and sample size determination /power calculation, writing the statistical sections of protocols through to the writing of the integrated Clinical Study report
- All programming performed in SAS under Git version control ensuring a reliable code base
- Experienced in working with data safety boards, conducting and planning for adaptive trial designs and consultation
Medical & technical writing
Our Medical Writing team has extensive experience in a wide range of therapeutic areas covering Phase I through Phase IV of global clinical development, including:
- Infectious Diseases
The team is flexible to your needs and can adapt to your specifications, including varying operating procedures, templates and style guides. We can support sponsors who do not have in-house templates through our own set of document templates, compliant to industry standards and requirements.
The Medical Writing team offers appropriate guidance using the team’s expertise and knowledge whilst abiding to industry and regulatory requirements.
We ensure timely delivery of documents and work closely with key operational departments including Biostatistics, Medical Affairs, Clinical Operations, Scientific Affairs, Pharmacovigilance, Regulatory Affairs, Data Management and Quality Assurance to produce the highest quality documents.
All documents produced undergo thorough reviews by the key operational departments and quality checks to ensure the highest standards.
Medical Writing documents and services include:
- ICH GCP compliant Clinical Study Reports (CSRs) Phases I to IV, including CSR synopses for public disclosure, rewriting or amalgamation of existing CSRs and electronic Common Technical Document (eCTD) formatting of CSRs
- Patient Safety Narratives (for CSR inclusion)
- Study Protocols, Amendments and Administrative Changes
- Development Safety Update Reports (DSURs)
- Investigator Brochures (IBs)
- Investigational Medicinal Product Dossiers (IMPDs)
- Standalone quality checks
- Certified translations of medical writing documents
Our considerable experience in human pharmacology studies, spanning First-into-Human through to bioequivalence studies provides invaluable support for both early and later phase clinical development programmes. We can integrate PK/PD data analyses into any phase of development to optimise decision making and ongoing study design considerations.
Using industry-leading Phoenix WinNonLin PK analysis software, our solutions include Non-compartmental and compartmental analysis, Rapid turnaround of PK analysis for dose escalation decisions, Routine PK analysis for demonstrating bioequivalence, Preclinical PK calculations, PK/PD input to guide protocol design, PK/PD modelling and simulation, statistical analysis and interpretation of PK and PD outcomes for the Clinical Study Report.
Bioavailability & Bioequivalence Studies
Full service solutions for generic or innovative study drugs.We routinely design and perform a variety of different BA/BE study designs to support our clients’ clinical development. These include:
- Formal bioequivalence assessment for generic products
- Formulation development and comparison between dosage forms
- Drug-Drug Interactions
As an independent bioanalysis laboratory, the analysis of samples generated through the various stages of your programme can be undertaken without having to transfer your assays when you switch clinical providers. This retains the knowledge base, proving more cost efficient over time and mitigates risk from your process.
A significant proportion of the bioanalytical laboratory services experience has been with new chemical entities and this is reflected in the adaptability of the team. Methods are either developed or cross validated from pre-clinical methods and subsequently validated to FDA and EMA regulatory guidelines for the conduct of bioanalytical validations. We also have experience in transferring methodologies from other laboratories.
Our dedicated scientists with 100+ years of combined experience in the bioanalytical and method development fields will ensure that a robust, reproducible and specific method is in place to achieve:
- Extremely low LLOQ
- Ability to use low sample volume
- Large dynamic ranges
- Analysis of multiple metabolites
- Analysis from various matrices (plasma, serum, CSF, blood, urine, etc.)
- Quick method development for high throughput assays using strict criteria
- Rapid method transfers or optimisation
- Overcome challenges such as stability issues and matrix effects
- Methods free of interference from metabolites
Consideration to adaptive protocols is also undertaken during the validation process:
- Batch size maximised to allow for increase in sample numbers in a profile.
- If required, additional validation is performed during the study to extend calibration range, if majority of samples on higher doses give concentrations that fall outside of the already validated calibration range of the method.
Gamma scintigraphy is a safe non-invasive method for determining the biodistribution of drug delivery systems under physiological conditions, providing valuable data earlier on in the drug development process. In partnership with Cardiff Scintigraphics Limited, this method is routinely employed using our on-site gamma camera to successfully evaluate deposition, residence, clearance and dispersion of pharmaceutical dosage forms under physiological conditions.
Depending upon the study objectives, protocols may include whole body and regional imaging using planar scintigraphy, or SPECT techniques. The scintigraphic analysis can also be complimented with expertise in pharmacokinetic and pharmacodynamic evaluations, drug assay development and bioanalysis.
The successful application of scintigraphy is dependent on direct or indirect labelling of a component of the dosage form with a suitable gamma-emitting radioisotope such as Technetium-99m or Indium-111.
In the respiratory tract, the performance of delivery systems is assessed by evaluation deposition and residence in the oropharyngeal and central and peripheral regions of the lung. Furthermore, physiological functions such as mucociliary clearance may be studied using this technique.
Gamma scintigraphy is also routinely used to characterise drug delivery from oral dosage forms, factors such as gastric residence/emptying, gastrointestinal transit and the site of disintegration/dispersion can be determined.