COMAC MEDICAL Ltd

As one of the most experienced and leading CROs (Contract Research Organization) for over 35 years, McDougall delivers valuable insight to biotech and pharmaceutical clients across all phases of their clinical trials. With timely, accurate data and analytics, we help clients expedite their time-to-market and lower development costs.

McDougall Scientific specializes in Clinical Trial Design services, Statistical Analysis and Clinical Data Management. Known for delivering insights you can trust, we take the time necessary to understand your business requirements, align with your regulatory strategy, and mitigate risks to deliver a vital statistical strategy for the development of your product.

The result: a smooth, efficient, and trusted operation from start to finish. We welcome you to contact us whether you are a company with established assets, or an independent investigator exploring initiating an investigator trial.

Specialties:

Feasibility Assessment, Protocol Development, Study Startup, Project Management, Investigator Initiated Trials, Phase I-IV Trials, Clinical Data Management System, Statistical Services, EDC, Data Management, Supply Management, Randomization, Document Management, Clinical Trial Management, Site Monitoring, Medical Writing, Regulatory Services, Pharmacokinetics, Patient Recruitment,​ Pharmacovigilance, Safety Surveillance, Integrated Safety, Risk-based monitoring

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.

DP Clinical, Inc. is a privately held Contract Research Organization (CRO) specializing in neurology/CNS (including spinal cord injury), oncology, ophthalmology, infectious disease/vaccines, and rare disease Phase I-IV clinical programs. DP Clinical provides a full complement of clinical trial services to pharmaceutical, biotech, and medical device companies including trial management, monitoring, data management, biostatistics, regulatory, safety monitoring and reporting, and medical writing. Since 1994, we have worked for clients of all sizes — small to large pharmaceutical and biotech companies, academic research institutions, and government sponsors.

DP Clinical provides integrated trial solutions as well as specific service components based on sponsor need. Our comprehensive services include:
• Project management
• Clinical trial monitoring
• Data management
• Biostatistics
• Pharmacovigilance and safety
• Regulatory affairs
• Quality assurance
• Medical writing

OCT is the leading contract research organization in Russia. Since 2005, OCT’s team has conducted over 300 clinical trials in Eastern Europe and the CIS region. Our team of 150+ clinical professionals provides a full range of high-quality CRO services for Phase I-IV and BE studies, with therapeutic expertise in oncology, infectious disease, and all major therapeutic indications.

As pharmaceutical and biotechnology companies have turned toward outsourcing models in clinical research, OCT has established itself as one of the top contract research organizations worldwide. With strong local expertise and focus on quality, OCT ensures seamless clinical trial conduct and drug registration, on time and within budget.

Our experienced team delivers a full range of CRO services:

Clinical Study Design Preparation
Medical Writing
Consulting and Regulatory Support
Project Management and Monitoring
Drug Safety and Pharmacovigilance
Data Management
Biostatistics
Clinical Supply Services and Logistics
Marketing Authorization
GMP Inspection Support

Over 10 years ago, Peachtree was founded to fill a perceived missing principle in typical CRO services. Where can I find a CRO that will partner with me, understand my challenges, and solve issues to keep my program on track? Filling this need requires experienced clinical research professionals.

We focused on people – building an organization by investing in highly experienced personnel with broad therapeutic area expertise in a number of clinical trials. From single-center Phase I to global multi-center trials. Most all of our clinical personnel have both sponsor and CRO experience – allowing us
to fully understand the issues our sponsor-clients face. We built a rock-solid processes and systems infrastructure to support the teams and this investment continues today – always seeking to improve our service.

We also saw the opportunity to support an under-served segment of the market – emerging mid-sized companies. We felt they could benefit from access to highly-experienced teams that understand the challenges of limited resources and be flexible, reliable, and responsive. Most of all – provide solutions.

So where is Peachtree today?
? A full-service CRO offering project management, feasibility & subject recruitment, clinical site management & monitoring, data management, biostatistics, medical monitoring, medical writing, and
clinical quality assurance
? We are 80+ highly-experienced clinical research professionals with an average of more than 20 years relevant clinical experience
? Our client roster continues to grow having worked with nearly 100 pharmaceutical, biotech, and medical device companies providing full-service clinical trial support to niche services
? Continued investment in best-in-class systems such as IBM Clinical for EDC, Veeva Vault for eTMF, ZenQMS for quality management and training, and Oracle for CTMS.