Clinical Research | Data Management | Medical Communications | Consultancy

Who are The Micron Group

The Micron Group is an international contract clinical research organisation, specialising in data management and the development of anti-infectives.
We have offices in the UK (Cambridge, Slough, Bournemouth), USA (Lenexa Kansas) and South Africa (Pretoria).

Project management

Our project managers develop the partnership with the sponsor to ensure clear lines of communication and achievement of time and management deliverables. Members of our project management team consult with sponsors from project conception to FDA panels, to product launch and surveillance.

Project management services include:

• Protocol and case report form development
• Site selection and management
• Vendor selection and management
• Investigator meeting organisation and management
• Cross-functional study team guidance and management

Site monitoring

All studies are monitored by CRAs who have been trained according to Good Clinical Practices, ICH Guidelines, applicable country-specific regulations, and internal Standard Operating Procedures.

• All monitors are provided with therapeutic overview and protocol training before study start.
• Micron CRAs have been recognized as professional, detail oriented, easily accessible, and able to effectively manage their sites.
• Due to our CRAs' rapport with sites, site personnel have often recommended Micron CRAs to study sponsors and other investigative sites for future opportunities.
• Micron CRAs initiate methods to maintain or improve patient recruitment, efficient collection of data, and rapid query resolution.

Phase I through to IV

In the past decade Micron has successfully managed over 50 studies, from single site to multicenter studies, in diverse therapeutic areas.

Micron has partnered with sites in Eastern and Western Europe, South and Latin America, Australia and New Zealand, Hong Kong, North America including Canada, and South Africa, and has global contacts in other regions.

click to view case study

Drug distribution

A subsidiary of Micron, LogicTrials SA (Pty), handles drug distribution throughout Africa.

www.logictrials.com

Clinical study data management

Our experienced data management staff can provide:

• Data project management
• Protocol review
• CRF design
• Database / eCRF build
• Double data entry
• Data review / Query management
• Suite of study management reports
• Custom reports to meet specific sponsor requirements
• Coding (WHO Drug, MedDRA)
• Vendor data management
• SAE reconciliation
• Custom data transfers

Statistics

Our team of statisticians have many years' experience in the field of clinical studies, providing:

• Protocol review
• Sample size / power calculations
• Statistical Analysis Plan (SAP) creation / review
• SAS programming
• Tables, figures and listings
• Statistical analysis
• Clinical Study Report (CSR) input and review

Programming/development

Micron Data Centre's programmers are experienced in a number of languages including:

• SAS
• PHP
• Javascript
• HTML
• Actionscript
• Python
• Pearl
• Ruby

Products developed by our core team include:

• SILK EDC
• Surveillance studies
• Data analysis websites
• Educational / Training products
• Events Analyzer

Powerful Reporting

Micron SILK EDC provides powerful standard reports with drill-down capabilities covering all aspects of study management.

These reports enable users to quickly identify potential study problems, such as:

• query management problems
• sites with slow recruitment
• site monitoring issues
• CRF problem areas raising excessive queries

Customers may define their own reporting requirements, allowing for rapid generation and implementation of customised reports.

Subject profiles are generated on request, providing an up-to-date view of each subject's CRF data.

SILK EDC employs industry-standard SAS® software, ensuring that the speed and complexity of reporting available is second to none.

(SAS is a registered trademark of SAS Institute Inc. Cary, North Carolina, USA)

Online accessibility

Study Contacts

• Project managers and monitors can easily communicate with key contacts - monitors, investigators or laboratories - within the SILK EDC application through the use of the contact module.

Document Distribution

• Key documentation is always available online, including study protocol, entry guidelines, monitoring guidelines, newsletters and protocol updates.

Subject Profiles

• Subject profiles can be generated online within Micron SILK EDC, providing up-to-date views of each subject's complete CRF data in PDF format for review by authorised personnel.

Intuitive & powerful

• SILK EDC is easy and effective to use and assures reliable data delivery for project managers, monitors and study site staff via a secure environment.
• The use of flexible reporting and management features accelerates the progress of clinical studies.

Rapid study set-up

• Most EDC systems require database and validation rules to be established before a study commences, often resulting in subject enrolment delays.
• Micron SILK EDC's validated process enables rapid database set-up and deployment.
• SILK EDC's modular data validation structure allows for flexible management of data consistency rules, reducing time to deployment.
• The flexibility of SILK EDC allows for both traditional paper and electronic data capture to be used within the same study.

Streamlined data entry & monitoring

• Micron SILK EDC possesses a simple and intuitive interface which allows for rapid data entry.
• The user is guided through the eCRF, improving data entry accuracy.
• Online checks ensure data consistency.
• Accurate data entry and review are encouraged through hierarchical menus with a clear flagging system for subject status.
• Monitor-investigator interaction tools allow for rapid query management and resolution.
• Study data can be locked at centre, subject and/or record level.

Online coding capabilities

• Micron SILK EDC's online coding uses MedDRA and WHO Drug dictionaries, although customer-specific dictionaries can be employed on request.
• Simple or complex searches may be carried out using our intuitive coding interface.
• The use of interactive coding reports ensures consistency across a study.

Reliable

• SILK EDC's innovative data structures and data processing techniques allow efficient response times and rapid data entry, even on slower user-level bandwidths.
• Rigorous quality control procedures and extensive validation testing ensure rapid and reliable performance.

Complete security

• Our security model ensures that data cannot be accessed by unauthorised users.
• All data transactions take place using industry standard encryption, ensuring data security.
• Micron SILK EDC runs in a highly secure environment with robust disaster recovery and backup systems.

Regulatory compliance

• We comply fully with all international regulatory guidelines regarding e-clinical studies.

Serious Adverse Event (SAE) alerts

• Project personnel can be alerted immediately upon the generation of a serious adverse event.

Publication strategies

Our Communications team has extensive experience in working with clients to develop key messages and to deliver those messages to the right audience, at the right time, using appropriate media.

Symposia & meeting organisation

Our Communications team has extensive experience in organising highly successful investigator meetings and advisory boards, scientific exhibition booths, internal client meetings and satellite symposia. We offer a tailored approach and can provide either a full conference service or selected elements.

Too busy to attend a congress? We can attend on your behalf and produce a full report as required.

Medical writing

Papers, abstracts, posters
Our acceptance rate for publication of peer-reviewed scientific papers in premier journals is 98%. We offer a full service for the production of posters for conferences, from preparation of text and figures, through design and layout, to large-scale printing.

Product literature
We produce high quality medical product monographs, as well as succinct newsletters to enable the rapid circulation of news, results and product updates.

Slide kits/animated slides
We can incorporate animated 2D and 3D sequences into slides - valuable as pictorial aids. In addition, our own in-house software (SILK showcase) enables the seamless presentation of static and animated slides, and dual screen presentations.

Training materials
We produce leaflets, booklets, CDs, videos and slide kits. We can also provide interactive on-line training and face-to-face training at dedicated workshops.

Regulatory writing

Our Communications team provides regulatory writing services, from pre-Phase I and throughout the lifecycle of the product, for a wide range of therapeutic areas. These include writing and editorial support in the production of clinical study protocols and reports, investigators' brochures, and other regulatory submission documents.

Website & graphic design

Our team of graphic designers can help you develop your brand identity by producing bespoke...

• Posters
• Publications
• Brochures
• Websites
• Logo design
• Stationery design

Data analysis interpretation

Our Medical Communications and Data Management teams work closely to ensure stringent data analysis and scientific interpretation.

Resistance surveillance studies include:

• Alexander for SKB/GSK - Global respiratory tract infection (RTI) pathogens
• Nearchus for London Hospitals - UK, RTI pathogens and outcomes
• BSAC for BSAC - RTI pathogens and bacteraemia
• AEGIS for Aventis - European Glycopeptide Resistance Surveillance
• MYSTIC for Astra Zeneca - Meropenem Yearly Susceptibility Test Information Collection
• PROTEKT for Aventis - Prospective Resistant Organism Tracking for the Ketolide Telithromycin: >120 sites globally
• PROTEKTUS for Aventis: >250 sites across the USA
• Resistance Matters for Aventis - Synthesis of PROTEKT US and prescribing data
• TEST for Wyeth/Pfizer - Tigecycline Evaluation and Surveillance Trial: >800 sites in 53 countries

Ian Harding, PhD
click for Ian's bio

Miriam O'Hare, PhD
click for Miriam's bio

Iain Simpson, PhD
click for Iain's bio

Robert Flett, ACCA
click for Rob's bio

Esam Sidarous, BSc, BPharm, MS
click for Esam's bio

Russell Outlaw, BSc
click for Russells's bio

Anita Lessing
click for Anita's bio

Cambridge  |  UK

Micron Research, Zion building, Park street
Chatteris, Cambridgeshire, PE16 6AE

Tel: +44(0) 1354 697693
Fax: +44(0) 1354 697691

Click to use contact form

Lenexa  |  Kansas USA

US Micron, 15361, West 95th
Lenexa, Kansas 66219

Tel: +1 913 495 6380
Fax: +1 913 438 1913

Click to use contact form

Pretoria  |  SA

ClinDev, Route 21 Corporate Park, 5 Regency Drive
Building 1, Irene 0062, Centurion SA

Tel: +27 12 345 5266
Fax: +27 12 345 5116

Click to use contact form

electronic data capture

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