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Sourcing Inquiry Logo Bioskin

Bioskin

Regions
Europe
Countries
Germany
Size
n.e.
Specialty
Human Medicines, Cosmeceuticals
Service category
Certification services, Pre-clinical development and testing, pre-clinical CRO, …
Service category
Certification services, Pre-clinical development and testing, pre-clinical CRO, Clinical development and testing, clinical CRO, Regulatory services - CMC writing - medical writing, Others
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Key services

Services

In-house studies

At bioskin’s clinical units in Hamburg and Berlin we perform Phase I and Phase II safety and efficacy trials for pharmaceuticals, medical devices, food supplements and advanced/professional cosmetics.

Safety Studies

Investigation of cutaneous safety is a critical component of topical product development for both pharmaceuticals and cosmetics.

At bioskin® we are experienced in the design and conduct of the entire spectra of cutaneous safety studies and offer a battery of safety tests required for assessment of products which are applied locally and exert their effects at the site of application. 
In addition we conduct trials evaluating systemic safety (e.g. ECGs, clinical chemical parameters, systemic absorption) and histological / immunohistochemical effects.
Designs for evaluation of safety include:

  • Dermal irritation (diverse models)
  • Ocular tolerability
  • Sensitization potential
  • Phototoxic and photosensitization potential
  • Systemic absorption and pharmacokinetics
  • Skin atrophogenic potential
  • Dermal tolerability and sensitization potential of transdermals

Efficacy testing / Proof-of-Concept trials

A core expertise at bioskin® is development of innovative test models for evaluation of efficacy of topical drugs and medical devices. In these models biophysical measurement methods can often be used to deliver objective data to support traditional clinical endpoints. We customize designs for efficacy trials depending on the indication and product profile.
Routine in-house Proof-of-Concept / efficacy trials include:

  • Psoriasis plaque test (for anti-psoriatics, also for screening of generic formulations)
  • UV-induced erythema model (for anti-inflammatories)
  • Pain model (for topical analgesics, anti-inflammatories)
  • Vasoconstrictor assay (for corticosteroids)
  • Superficial wound healing (abrasion model, suction blister model for re-epithelization)
  • Expanded flora test (for anti-bacterials)
  • Acne/rosacea
  • Alopecia/hair growth
  • Atopic dermatitis
  • Onychomychosis
  • Psoriasis
  • Tinea pedis

Claim support studies

Independent, well-designed clinical claim support studies are crucial to ensure that claims are adequately supported and correlate with the study objectives.
bioskin® offers claim support studies in the following fields:

  • Antiperspirants
  • Dandruff
  • Eye tolerability
  • Fillers and injectables
  • Hair growth / hair removal
  • Hygiene products
  • Oral care
  • Peelings
  • Skin ageing
  • Skin barrier function and hydration
  • Skin protection

Biophysical measurement methods

One of our special areas of expertise is the application of biophysical measurement methods to evaluate the effect of topical product candidates, cosmetics and food supplements on skin structure and function, hence our name bioskin®. 
Some of the biophysical measurement methods bioskin® offers include:

  • Colorimetry
  • Corneometry
  • Cutometry
  • Laser-Doppler flowmetry
  • Skin surface pH measurement
  • Phototrichograms
  • Raman spectroscopy
  • Sebumetry
  • Sonography
  • Transepidermal water loss (TEWL)
  • Thermal sensory assessment (TSA)
  • Visia CR for facial imaging

Multicenter, multinational trials

bioskin® has an extensive network of investigators and partners which enable reliable and fast feasibility, site selection and trial set-up for large multicenter trials. Our flexibility and dedication to detail, coupled with our expertise over the entire field of dermatology, set us apart from other CROs. Our project teams are fine-tuned with members from clinical trial management, monitoring, data management, statistics and medical writing.

Clinical Trial Management

The clinical trial manager is at the heart of every clinical trial. Every project at bioskin® is assigned a dedicated clinical trial manager who heads up the project team and coordinates all activities from protocol development through reporting and archiving. Our clinical trial managers are flexible and proactive, keeping a close watch on timelines and budget. They recognize that your goals are our goals and are committed to ensuring that they are met.
Clinical trial management services include:

  • Planning of resources and study logistics
  • Investigator selection and recruitment
  • Training of team members and monitors
  • Coordination of interaction between team members
  • Organization of team meetings
  • Budget overview
  • Selection of laboratories and external vendors
  • Clinical Trial Application (CTA) submission
  • Submission for ethical approval
  • Organization of investigator meetings
  • Status reporting and ongoing communication with client
  • Supervision of monitors
  • Maintenance of trial files and archiving

Monitoring

bioskin®s monitors/CRAs strive to maintain an excellent relationship with the investigator and site staff as well as the sponsor, ensuring that your trial runs smoothly and stays on schedule. At the same time they guarantee that trials are conducted in accordance with the protocol, Standard Operating Procedures (SOPs), and Good Clinical Practice (GCP) as well as applicable guidelines. 
Our monitoring services include:

  • Feasibility
  • Site selection
  • Pre-study qualification visits
  • Site initiation
  • Organization of investigator meetings / trainings
  • Preparation and collection of regulatory documents
  • Clinical study logistic handling
  • Patient recruitment strategies
  • Periodic site monitoring
  • Query resolution
  • Site termination

All services can be offered according to bioskin® or sponsor SOPs.

Data Management

bioskin® uses validated, robust systems for in-house data management which allow for tailoring of individual databases to meet the client’s requirements. We offer paper-based data collection as well as EDC(Electronic Data Capture) and ePRO (electronic Patient Reported Outcomes). Flexibility of our processes allows us to maintain data quality while adhering to timelines, even in the face of changes to data collection specifications during an ongoing trial. Our data management processes are compliant with ICH GCP and 21 CFR Part 11.

Data management services are offered as stand-alone services for dermatological and other therapeutic areas as well as part of full packages and include:

  • General counseling in DM aspects including EDC and other vendor selection
  • CRF development and instructions for investigator / monitor
  • Training in EDC system and DM aspects (internal, sites, external, sponsor)
  • Presentation for investigator meeting (DM aspects of study project)
  • Providing status data on trial database and query process for sponsor
  • Handling/import of external data (ePRO, laboratory data, images, etc.)
  • Preparation for interim analysis / snapshot of data
  • Medical coding (MedDRA and WHO Drug ATC)
  • SAE reconciliation
  • Medical review preparation/coordination

All services can be offered according to bioskin® or sponsor SOPs.

Statistics

At bioskin® our statisticians are involved in a project from the earliest stages of clinical trial planning. They have a comprehensive understanding of the sponsor’s goal and study objectives, information which is essential to determining the ideal methods for collecting and analyzing your data. Data presentations are optimized according to the client’s requirements.

Statistical services are offered as stand-alone services for dermatological and other therapeutic areas as well as part of full packages and include:

  • Statistical consultation on study design
  • (superiority, non-inferiority, equivalence trials, phases I, II, III, IV)
  • Protocol development and statistical design
  • Sample size calculations, power analyses
  • CRF consultation (e. g. adherence to trial protocol)
  • Randomization services
  • Statistical Analysis Plan (SAP) development, generation of table shells
  • Statistical analyses including interim analyses
  • Statistical programming (validated SAS and nQuery Advisor installations)
  • Blind data review
  • Statistical reporting (integrated into study report or stand-alone statistical report)
  • High quality output of tables, listings and figures (ASCIISAS ODS)
  • Support for presentations or scientific publications
  • Electronic data transfer (also customized formats)

All services can be offered according to bioskin® or sponsor SOPs.

Medical Writing

bioskin® provides medical writing that is clear, comprehensive, carefully focused and precise. The documents are standards-compliant and can be quickly and easily read and understood by scientific, medical and regulatory professionals.

Medical writing services are offered as stand-alone services and other therapeutic areas as well as part of full packages and include:

  • Clinical Study Reports (CSRs) according to ICH-E3 for single- and multi-center trials
  • Preparation of appendices for CSRs
  • Linking and bookmarking processes
  • CSRs in Common Technical Document (CTD) or electronic Common Technical Document (eCTD) for application dossier
  • Research reports for non-drug studies, as well as abbreviated reports
  • Study protocols, subject information leaflets
  • Scientific publications (journal articles, abstracts, posters)
  • Editing and review of documents assuring that documents comply with regulatory, journal, or other guidelines in terms of content, format and structure

All services can be offered according to bioskin® or sponsor SOPs.

Regulatory and Consulting

The regulatory pathway for dermatological products, in particular topically applied products, differs from those for other therapeutic indications and dosage forms.

Early development of proper strategies can shorten timelines and reduce costs. bioskin® can help you put together a regulatory team composed of internal and external consultants to develop specific strategies which will speed development from candidate selection through the approval process while managing risks. 

Approvals, Certificates, Authorisations

  • GCP

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