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Sourcing Inquiry Logo Asian Clinical Trial (ACT)

Asian Clinical Trial (ACT)

Regions
North America, Asia
Countries
India, United States
Size
20-50
Specialty
Human Medicines, Biopharmaceuticals, …
Specialty
Human Medicines, Biopharmaceuticals, Medical Devices
Service category
GMP audit services, GLP services, …
Service category
GMP audit services, GLP services, GCP audit services, Clinical development and testing, clinical CRO, Analytical laboratory and testing services, eData - IT - software, Regulatory services - CMC writing - medical writing, Pharmacovigilance and QPPV services, Others
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Key services

Services

ACT offers a range of services to guide pharmaceutical, biotechnology, and medical device companies in getting their new products reach the market soon. 

* Phase I/ II/ III/ IV Clinical Trials 
* Post-Marketing Surveillance 
* Clinical Data Management 
Our team with expertise in regulatory controlling, project management, safety management, study supply, logistics management and medical writing provide expertise in conduct of clinical trial in India with efficient manner meeting the quality as demanded by the sponsors. 

 

Regulatory Affairs 

We understand that ‘time is money‘, so our aim is to assist you with a broad range of regulatory affairs services that can help you in successful submission at the shortest time possible for all the phases of the drug development and approval process 

*Strategic Planning* 

* Complete regulatory strategy planning 
* Product development strategy 
* GAP analysis and Corrective action plan 
* Dossier preparation 
* Submission planning for all stages 

*Relation Development and Interaction* 

* Complete planning of regulatory agency interaction 
* Interaction/s with regulatory agencies 
* Assessment of issues, its analysis and resolution 
* Creation of operational link between regulatory agencies and sponsor 

*Submission and Tracking* 

* Filing of all submission 
* Submission tracking 
* Strategic query resolution 

Clinical Research 

ACT is composed of highly experienced professionals in the field of clinical trials. ACT designs and conducts for both small and large national and multinational pharmaceutical, biotechnology, and medical device companies . 
ACT stands for quality that meets all of the requirements of its customers in a professional way that is free of ethical, regulatory, and scientific deficiencies. For us, quality is embedded in every aspect of the business. 

Project Management 

Our project management team provides the leadership to plan and integrate cross-functional activity to keep projects on time and on budget with a devotion to quality assurance throughout 

* Recruit investigators through our direct contact and in-house investigator database 
* Train investigators and site personnel 
* Patient recruitment and retention 
* Prepare clinical development plan 
* Randomization, repackaging, coding and labeling of investigational drugs 
* Schedule monitoring activities 
* Arrange and conduct steering committee meetings 
* Provide clean and locked data 
* Archiving 
* Study site support 
* Site feasibility studies 

Clinical Trial Conduct 

 We provide a wide range of clinical research services at the study site to meet quality and ICH-GCP compliance at the highest level 


* Site/Investigator identification and selection 
* Site initiation 
* Medical monitoring 
* Study close-out 
* Query Management 

Clinical Compliance 

 Clinical compliance services include audit service for Investigator sites as per protocol, SOPs, ICH-GCP and other regulatory requirements 


* ICH-GCP compliance review 
* IRB audits 
* On-site investigator audits 
* Drug accountability reviews 
* Clinical compliance per protocol 

 

Medical Services 

ACT medical services team comprises of highly experienced professionals in different therapeutic areas. They bring in experience and expertise in efficient management of issues related to safety reporting, clinical study, report writing, training on project and study related matters. The group ensure that subject safety is foremost in mind and provide adequate information to investigators for safe and efficient trial conduct. 

 

 

 Medical Writing 

 

Our medical writers have a strong academic, pharmaceutical, and biotechnology industry background and can help you prepare clear, concise, and high quality: 

* Investigator Brochure 
* Protocol 
* Case Report Form 
* Patient information leaflets for clinical trials and package inserts 
* Informed Consent Form 
* Safety data reports 
* Statistical analysis plan 
* Medical translation services 
* Regulatory submissions 
* Clinical Study Report 

 

Safety Surveillance 
 

Our team is available on 24/7 response line to take medically related questions or for reporting adverse events. Safety surveillance and reporting services include: 

* Review of Protocol, Investigator Brochure, Informed Consent Form, and Case Report Form 
* Safety monitoring 
* Serious Adverse Event collection, evaluation, classification and reporting to Central IRB/ Sponsor/ Regulatory authorities 
* Unblinding during Serious Adverse Event 
* Developing safety database 
* Periodic safety update reports 
* Organize IDMB 

 

 

Data Management 

 

ACT provides sophisticated solution that helps meet this challenge, through Oracle Clinical® version 4.5. Our solutions are complete with the integrated Remote Data Capture allowing companies to rethink some of the traditional data management processes. 

At ACT, Oracle Clinical® automates study design, data collection, data management and regulatory submissions, using an architecture that can scale to handle hundreds of studies per year. This will help our customers to bring medical products to market faster and at lower cost. 

 

 

Data Management Services 

 

Asian Clinical Trials works on fully integrated Clinical Data Management solutions. ACT assurance to clients is to provide clean data with speed and accuracy, keeping cost in mind. ACT has strong systems with SOPs to handle all modes of data capture Paper, Fax and Web. Our people have more than 2 decades in handling different data management solutions. 

Our backup and disaster recovery systems takes the worries off the customer in putting back the systems in time and our 24/7 support on data management solutions provide unparallel assistance during the conduct of trial. The security protocol with full firewall setup ensures taking care of multiple levels of authorizations with complete audit trail of the activities from initiation till end. This will also enable transactions occur through secured internet connection with sound intrusion detection system, where by the data are transferred very much safe using SSL 128 bit encryption. 

ACT also offers customized reports to customers at timely and periodical intervals to get the complete feel of the conduct of study. 

Our services include: 

* Database & eCRF design 
* CRF management 
* Double data entry 
* Electronic data capture 
* Web and Fax based receipt of CRF 
* Data validation and review 
* Medical coding using MedDRA 
* SAS® programming 
* Data processing and migration 
* Data generation for analysis 
* Trial scalability and site flexibility 
* Transparent/seamless data conversion 
* Quick setup time and economical cost 
* Randomization and trial supply management for multi-center trials 


Biostatistics 

 Our in-house biostatisticians will provide crucial analytical expertise for coordinating clinical trials and consult with outside groups on a contract basis. Our statisticians are involved in trials from design to total analyses or published manuscript, and beyond. Our aim is to deliver accurate, clean and locked database on time. 


*Our biostatistical services include:* 

 

*Protocol Preparation* 
Development of study design Sample size/statistical power determination Formulation of statistical analysis section of protocols Describe both interim and final analysis strategies 

 

*Consultation/Planning* 
Consult on statistical problems Prepare for discussions with regulatory agencies Hold planning sessions with customers to interpret or clarify analyses 

*Report Preparation* 
Prepare integrated clinical/statistical reports Design tables and graphics Summary of all statistical methodologies and results 

*Submission Support* 
Support submissions to regulatory agencies Present to regulatory agencies at advisory committee meetings 

 

IT Services 

 

Our IT Team provides technology support in every aspect of clinical research program, be in managing solutions at site or providing critical backup support. ACT has technology and experience meeting global standards. The wide array of services offered by ACT help the team and also our sponsors in meeting the challenges in conduct of clinical studies. 

* 24 x 7 Help desk 
* Clinical trial management support systems 
* Imaging database support Services 
* Global data integration 
* Web portal management 
* Document management 
* Site setup and support services 
* IVRS 

Special projects

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