Services

1. Sterile Dosage Forms 2/22/2012

   DSM manufactures sterile dosage form pharmaceuticals, comprising aseptic liquid filling, cytotoxic formulation and filling, and lyophilization.

2. Medical Writing

   Writers with both industry and therapeutic expertise
   Each member of our core regulatory and medical writing team draws on extensive industry knowledge and therapeutic expertise to effectively meet our clients’ product development requirements and provide top notch medical writing services. Each writer is a graduate-level life science scholar. They enhance their scientific and technical expertise through continuing medical education and study-specific training. Our writers also have access to internal therapeutic experts, researchers, and academics to gain sophisticated insight across many therapeutic specialties. Their experience and training enable them to expertly prepare reports in accordance with regional regulations and ICH Guidelines and to create clinical trial and regulatory documentation suitable for submission to regulatory authorities, including FDA and EMA.

3. Clinical Operations 3/4/2016

   Clinical operations are a critical component in all studies. SynteractHCR’s highly skilled staff is well-versed in clinical trial operations including implementing, monitoring and managing the clinical components of a study. From start-up to close-out, experienced clinical managers and clinical research associates (CRAs) oversee each study’s clinical processes to ensure proper planning, conduct, patient safety, and data quality, while fostering good communication between study sites and sponsor.

4. IVRS/IWRS Services 3/4/2016

   SynteractHCR offers full-featured global Interactive Voice and Web Response Systems for your clinical trial operations, through our validated 21 CRF Part 11 compliant proprietary system. Once implemented, the system is available 24/7 for use by sites, study participants and project team members. Transactions are recorded into a study-specific database, and information can be exported into custom reports. Live technical support is available to sites and study participants via phone, email or web access. SynteractHCR has successfully implemented IWRS in 30 countries and has the capability to translate 26 different languages.

5. Medical & Regulatory Affairs 3/4/2016

   Taking new products successfully through clinical development, submission and approval can be a difficult, expensive and lengthy process. SynteractHCR’s medical regulatory affairs group offers a wide range of services that spans the full range of product development, including training, performed by senior regulatory professionals with experience in pharmaceutical, diagnostic, device and biotechnology industries. Our medical regulatory affairs team is here to deliver on aggressive timelines and control costs, while ensuring compliance and patient safety.

6. Medical Writing 3/4/2016

   As an international, full-service clinical contract research organization, SynteractHCR strives to deliver actionable results for your clinical trial needs. Our medical writing group consists of qualified Ph.D., M.D., and other experts, and our European medical writers are all members of the European Medical Writers Association. Our translation team consists of native speakers with many years of experience in translating all documents necessary for the performance of clinical studies. Our medical writers are committed to delivering a well-designed clinical program that will meet your study’s ultimate goals.

7. Biostatistical Services 3/4/2016

   Delivering high-quality and accurate data analysis, SynteractHCR is a contract research organization that provides robust and customized biostatistical services tailored to your study’s needs. At SynteractHCR, we believe that a statistician is a vital component in the clinical development process. Working as your partner, SynteractHCR’s expert biostatisticians will review your study’s needs and determine the best methods for collecting, analyzing and presenting your data, all in compliance with regulatory guidelines. Our team is trained to provide creative thinking and analysis optimized for your unique study designs. We provide access to your data in a format well-suited to your project requirements.

8. Clinical Research Services 1/11/2014

   Norwich offers a range of clinical services to the pharmaceutical and biotech industries. Our unique combination of clinical expertise, therapeutic experience, equipment and processes means that Norwich can manage and overcome challenges with specific focus on maximizing project budgets and meeting timelines.

9. Chiral Products and Technologies: Chirotech 5/22/2013

   Dr Reddy’s has been working in the area of pharmaceutical intermediates and active ingredients for more than 20 years.  The focus has been on technologies for preparing single enantiomer compounds with a particular emphasis on catalytic methods, both chemical and enzymatic.

10. Clinical Study Management 4/29/2013

    Our full-service capabilities allow us to handle an entire program or the services specifically needed by our clients, from protocol strategy to regulatory submission and post-marketing.