Clinical Development

• Management of Post-marketing Studies (PASS and NIS)
• IMPDs and Dossier compilation
• Scientific Advice
• Upload §42 AMG - clinical trials portal

• Long-standing experience in designing, planning, implementation, evaluation and publication of clinical trials to obtain/extend the product approval or optimize product marketing
• Studies for substantiation of Health Claims (according to current EFSA guidelines)
• Non-interventional studies (NIS), observational studies
• Core competences: Studies with herbal drugs, OTC / Rx drugs, dietary supplements, functional food / nutraceuticals, medicinal waters (drugs), substance-based medical devices, homeopathics
• Own study site/investigational site in Berlin: Recruitment of healthy volunteers and at-risk patients, bioequivalence studies

Advice and practical support regarding:

• Project management and study management NIS and clinical studies
• Planning, execution and evaluation of clinical studies (phase I-IV, late-phase), NIS and registries
• From investigator selection and meetings to Study close-out
• Preparation of documents relevant to the study and preparation of study submissions
• Supervision of monitoring activities and CROs
• Mentoring of Clinical Research Associates (CRAs)/Co-Monitoring
• Clinical Trial Liason (CTL)

• Strategic and scientific advice on the clinical development of pharmaceutical products meeting current and future regulatory requirements and standards
• Review, quality control or generation of scientific and clinical study related data, reports and essential documents according to ICH Guideline E6(R2)
  - Investigator’s Brochure (IB)
  - Clinical study protocol
  - Clinical study report
  - Study oversight and risk management plan

•           Generation of reports, summaries, expert statements, briefing books

• Organisation of and attendance at meetings with regulatory agencies (e.g., scientific advice meetings, protocol assistance meetings)
• Regulatory applications for
  - Orphan Drug Designation (EMA, FDA)
  - Paediatric Investigation Plan (EMA)
  - Pediatric Study Plan (FDA)
  - Clinical Trial Applications (CTA, IND)
  - SME status (EMA)

• Strategic designing of Pre-clinical & Clinical development programs for drugs and devices including
  - Pre-clinical studies
  - Bioavailability/Bioequivalence (BA/BE) and Phase I studies
  - Phase II to Phase IV and PMS studies
• medical writing
• Biostatistics and Statistical Programming Services
• Clinical Data Management (CDM)
• GCP Audits and training

Pharmexon is able to advise on aspects of the development of a medicinal product or device at any stage of development. More notably, our clients would like “strategic inputs” even at target selection stage. This is important to note in order to understand the local and global pathway a development must follow. We are able to apply our experiences to identify possible pitfalls and common problem that can occur. Our experts are able to design preclinical and clinical strategies, synopsis and protocol. We provide appraisals of data/ideas as well as set-up and facilitate interaction with Agency committees.

Some of the services offered in this area are:

• Clinical advice on “hybrid/505b2” developments of known APIs
• Classification/advise on pathway for most medicinal product types
• Regulatory/preclinical/clinical Strategy reports on new pharmaceutical forms/delivery systems/new administration routes/new dosages for purpose of business planning
• Biosimilar advice for truncated programs according to current guidelines
• Leveraging data from regional developments for global registration strategy and vise versa
• Drug Device combinations
• Advise on PK/BE strategy for standard and complex generics

PharmaLex is a leading provider of specialized services for the pharma, biotech and medical device industries.

We guide you from early strategic planning activities and non-clinical requirements through clinical development, regulatory submission processes and post-approval / maintenance post-launch activities. Our experts use technology enabled solutions to support you through the entire product lifecycle. We deliver exceptional results — going above and beyond the standard to deliver tailor-made solutions worldwide.

The PharmaLex Group now has over 1000 employees, with 33 offices in 21 countries and more than 600 satisfied clients worldwide.

• Clinical development program strategy and design
• Indication strategy and developments
• Target product profile development
• Clinical development strategy and plan, trial design, study endpoints accelerated approval
• Program and study-level biostatistical-regulatory strategy
• Regulatory landscape analysis and road map
• Expedited/Adaptive Pathways and Orphan Drug Designation support

Scendea is a leading product development and regulatory consulting practice serving the pharmaceutical and biotechnology industry. We are committed problem solvers, redefining the meaning of customer service, with a focus on reducing time-to-market and minimising development costs.  A combination of scientific excellence, industry experience and a collaborative approach enable us to deliver high-quality innovative solutions, which allow our clients to succeed.  Our international team offers strategic and operational support in the fields of quality/CMC, non-clinical/toxicology, clinical/medical and regulatory, which guide products efficiently from early development to marketing approval.