Actlabs (Activation Laboratories Ltd.)

Advanced BioScience Laboratories, Inc (ABL) is a leading contract research and manufacturing organization, that partners with our clients to support their vaccine and therapeutic development programs. We offer a unique combination of preclinical and clinical services designed to first address the scientific challenges often encountered during proof-of-concept, and then streamline process development and cGMP production of clinical supply.
ABL can assist with all aspects of production development including, but not limited to:
Basic and translational research
Vaccine and therapeutic product design
Animal models for preclinical evaluation including immunomonitoring , efficacy and potency
Cell line and process development
cGMP manufacture of cell banks and virus banks
cGMP manufacture of clinical supply for protein therapeutics, vaccines and live viral vectors

Ask about our 9,000 sq ft clinical GCLP immunomonitoring space and our vaccine and therapeutic testing services.

With a 50+ year history as a service provider to the life sciences industry, ABL brings a broad technical knowledge base, highly experienced work force, and seasoned project management to every program. Our goal is to become a seamless extension of our clients’ product development group – helping them advance today’s ideas into tomorrow’s medicines. Our history, capabilities and expertise allow ABL to provide solution based services to our clients.

Our vision is to conduct clinical trials better and more cost effectively than anyone else. We accomplish this by working with our clients to not only deliver the clinical trial effectively, on time and within budget, but also by leveraging our in-depth expertise to ensure the clinical trial is properly designed.

We believe there is increasing need for innovation, creativity and scientific expertise in clinical research, characteristics often synonymous with small Biopharma and hence, though we are proud to have a number of the world’s largest pharmaceutical companies as our clients, greater than 80% of our client portfolio is small Biopharma.

ACLIRES has performed trials for an international array of biotech companies as well as for some of the largest global pharmaceutical companies. With our broad access to patients and expertise, our aim is to rapidly initiate our client’s studies, even when a very special patient population is required.

Our services include:
- Early Phase Studies
- Late Phase Studies
- Recruitment
- Regulatory Affairs
- Monitoring
- Site Selection
- Scientific Services/Medical Writing
- Consulting
- Quality Management

As consultants for the pharmaceutical, biotech and device industries we know that teams assembled around product development and clinical trials need more than a competent project manager and top technology to be successful at delivering according to plan.

To be successful, project teams in the health industry need a leader, with a strong medical and industry background, that will inspire, coordinate their efforts, and act as a single point of contact or reference for all involved; sponsors, sites, CROs, data & safety monitoring committee, clinical endpoint committee, special labs, IRB, FDA.

Anabase, founded by two MDs with both clinical practice and industry experience, provides independent, dedicated, hands on, medical and regulatory guidance to your product development and clinical trial projects.

Biostat International, Inc., is a contract research organization designed to meet the needs of device and pharmaceutical companies by providing a full range of product development services. Since its founding in 1994, BSI has delivered quality biostatistical and data management services and has expanded into project management, clinical monitoring, and medical writing. Its sincere devotion to quality, personal attention, support and commitment has made BSI a client-favorite CRO. The rED Cap system design is based on the CDISC Operational Data Model (ODM) (http://www.cdisc.org/site/index.php), and features multiple layouts for eCRFs, powerful data validation capabilities for increased data quality, and an easy and intuitive process for clinical site coordinators to enter data and manage query tasks. It also allows Monitors to keep up to date with source verification and data entry status, and sponsors to view data and custom reports. BSI offers the rED Cap tool to its clients interested in data management services where BSI statisticians provide ongoing trending and review of data entered into rED Cap. Cost effectiveness and transparent work accountability are important components of all of our service.

Our goal is to assist you to properly plan and execute your clinical strategy to assure early FDA approval and expedite your product to market.

Clinstat Consulting was founded in 1999 by Patricia Hamilton, RN, MS.

Patricia is a clinical expert with over 25 years experience. She is a Registered Nurse and holds a Master's Degree in Business Management. She has had extensive senior level technical and management experience delivering clinical research plans and studies on time and within budget for Fortune 500 global corporations as well as for small companies and start-ups. She has set up and managed clinical departments from the ground level and has hands on experience in all phases of developing a clinical/regulatory strategy, securing investigators, site selection, protocol development, site monitoring, generation of final reports and writing FDA submissions. Patricia and her staff are well suited to guide start-up companies or assist established firms with any or all your clinical needs.